Upcoming Product-Specific Guidances for Generic Drug Product Development
Introduction
This web page provides information related to upcoming new and revised product-specific guidances (PSGs) to support the development and approval of safe and effective generic drug products, including the projected date of PSG publication, as a commitment under the Generic Drug User Fee Amendments of 2022 (GDUFA III). Upcoming PSGs for both complex and non-complex products that are planned to be published in the next 12 months are listed (these may be subject to change).
How often does FDA publish new and revised PSGs?
To support generic drug development and generic drug approval, FDA issues new and revised PSGs on a quarterly and as needed basis. These PSGs, including PSGs for both complex and non-complex generic drug products, when finalized, describe the agency's current thinking and expectations on how to develop generic drug products to specific reference listed drugs and are intended to assist the generic pharmaceutical industry with identifying the most appropriate methodology and evidence needed to support a specific generic drug’s approval. The published PSGs are announced in the Federal Register and made available to the public on FDA’s website.
What information is provided on this web page?
For new PSGs for generic drug products under development, this web page provides information on the active ingredient(s), the route of administration and dosage form, the reference listed drug (RLD) application number, and the planned publication month/year. In addition to this information, the list of PSGs for generic products under revision also includes the planned revision categories and brief descriptions. This web page describes FDA’s plans for issuing new and revised PSGs for both complex and non-complex generic drug products.
What do the different planned revision categories mean?
For revised PSGs, the planned revision categories briefly describe the nature of the anticipated revisions. Planned revision categories are defined as the following:
- Critical revision: PSG revision includes additional bioequivalence (BE) study(ies) or evidence recommended that is necessary to establish BE and support FDA approval reflecting a change in the safety or effectiveness of the drug product. The critical revision has a potential impact on all ANDAs including the approved applications. Holders of approved applications are also expected to address the change in the safety or effectiveness of the drug product reflected in a critical revision to maintain its FDA approval.
- Major revision: PSG revision includes additional BE study(ies) or evidence recommended that is necessary to establish BE and support FDA approval. Major revisions are categorized as in vivo major revisions and in vitro major revisions. Under GDUFA III, applicants or prospective applicants may request PSG teleconference if they have already commenced an in vivo bioequivalence study (i.e., the study protocol has been signed by the study sponsor and/or the contract research organization) to obtain Agency feedback on the potential impact of the new or revised PSG on its development program. Pre-submission or post-submission PSG meetings may be requested following feedback received at the PSG teleconference. Refer to GDUFA III Enhancements to the Pre-ANDA Program for additional details.
- In vivo major revision: PSG revision includes additional in vivo bioequivalence study(ies) or evidence recommended to support FDA approval.
- In vitro major revision: PSG revision includes additional in vitro bioequivalence study(ies) or evidence recommended to support FDA approval.
- Minor revision: Any revision to a PSG that is not considered critical or major, including but not limited to when a PSG is to be revised to add an in vivo or in vitro BE option, to clarify recommended study design, to certain study(ies), to provide alternative (less burdensome) approaches to the currently recommended study(ies), to add information on newly approved strengths of the RLD, or to make other recommendations that would not generally result in additional recommended bioequivalence study(ies) or evidence by an ANDA applicant necessary to support FDA approval. Minor revisions include both in vivo and in vitro changes.
- Editorial revision: PSG revision includes non-substantive changes such as updating external references, correcting grammatical issues, and streamlining the format of existing recommendations.
FDA will also provide specific information on the planned revision when such information is available for public release.
What is a complex generic drug product?
As described in the GDUFA III Commitment Letter and Classifying Approved New Drug Products and Drug-device Combination Products as Complex Products for Generic Drug Development Purposes (MAPP 5240.10), a complex generic drug product generally means the following:
- A product with:
- a complex active ingredient(s) (e.g., peptides, polymeric compounds, complex mixtures of APIs, naturally sourced ingredients)
- a complex formulation (e.g., liposomes, colloids)
- a complex route of delivery (e.g., locally acting drugs such as dermatological products and complex ophthalmological products and otic dosage forms that are formulated as suspensions, emulsions, or gels)
- a complex dosage form (e.g., transdermals, metered dose inhalers, extended release injectables)
- Complex drug-device combination products (e.g., auto injectors, metered dose inhalers); and
- Other products where complexity or uncertainty concerning the approval pathway or possible alternative approaches would benefit from early scientific engagement.
How often does FDA update this web page?
This web page will be updated each time FDA issues a new quarterly PSG batch. Each update removes the published PSGs and adds any new PSG under development or revision. This advance notice will help generic drug companies to plan for their development of generic drug products.
New and Revised PSGs for Generic Drug Products
Below is the list of PSGs for both complex and non-complex generic drug products that FDA plans to issue and the list of PSGs that FDA plans to revise in the coming year. While this list reflects FDA’s effort to be transparent regarding current plans for developing PSGs for generic drug products, it should be noted that timing may be subject to change.
Planned New PSGs for Complex and Non-Complex
Generic Drug Products
Updated August 22, 2024
| Active Ingredient(s) | Route of Administration | Dosage Form | RLD or RS Application Number | Product Complexity | Planned Publication | Updates |
|---|---|---|---|---|---|---|
| Acalabrutinib Maleate | Oral | Tablet | 216387 | Non-Complex | 11/2024 | No Change |
| Adapalene; Benzoyl Peroxide; Clindamycin Phosphate | Topical | Gel | 216632 | Complex | 11/2024 | No Change |
| Albuterol Sulfate; Budesonide | Inhalation | Aerosol, Metered | 214070 | Complex | 02/2025 | No Change |
| Allopurinol | Oral | Suspension | 016084 Dosage Form is subject of approved suitability petitions (FDA-2008-P-0209; FDA-2011-P-0740) |
Non-Complex | 11/2024 | Newly Added |
| Amikacin Sulfate | Inhalation | Suspension, Liposomal | 207356 | Complex | Beyond 12 months | Planned publication date change to a later date |
| Aprocitentan | Oral | Tablet | 217686 | Non-Complex | 08/2025 | Newly Added |
| Aripiprazole | Intramuscular | Suspension, Extended Release | 217006 | Complex | 11/2024 | No Change |
| Aripiprazole | Oral | Tablet | 207202 | Complex | Within the next 12 months | No Change |
| Aripiprazole | Intramuscular | For Suspension, Extended Release | 202971 | Complex | 02/2025 | Newly Added |
| Aripiprazole Lauroxil | Intramuscular | Suspension, Extended Release | 209830 | Complex | 11/2024 | No Change |
| Brimonidine Tartrate | Ophthalmic | Solution/Drops | 218424 | Non-Complex | 02/2025 | Newly Added |
| Budesonide; Formoterol Fumarate | Inhalation | Aerosol, Metered | 216579 | Complex | 02/2025 | No Change |
| Buspirone Hydrochloride | Oral | Capsule | 021190 | Non-Complex | 11/2024 | No Change |
| Cantharidin | Topical | Solution | 212905 | Non-Complex | 11/2024 | No Change |
| Capivasertib | Oral | Tablet | 218197 | Non-Complex | 05/2025 | No Change |
| Cefazolin Sodium | Intravenous | Powder | 211413 | Non-Complex | 11/2024 | No Change |
| Ceftobiprole Medocaril Sodium | Intravenous | Powder | 218275 | Non-Complex | 02/2025 | Newly Added |
| Cephalexin | Oral | Tablet | 063024 | Non-Complex | 11/2024 | No Change |
| Clobetasol Propionate | Topical | Cream | 209483 | Complex | Beyond 12 months | No Change |
| Clobetasol Propionate | Ophthalmic | Suspension/Drops | 218158 | Complex | 02/2025 | Newly Added |
| Clonazepam | Oral | Suspension | 017533 Dosage Form is subject of an approved suitability petition (FDA-2003-P-0122) |
Non-Complex | 11/2024 | Newly Added |
| Cyclosporine | Ophthalmic | Solution | 217469 | Non-Complex | 11/2024 | No Change |
| Danicopan | Oral | Tablet | 218037 | Non-Complex | 08/2025 | Newly Added |
| Desmopressin Acetate | Nasal | Spray, Metered | 201656 | Complex | 08/2025 | Planned publication date change to a later date |
| Dexamethasone; Neomycin Sulfate; Polymyxin B Sulfate | Ophthalmic | Ointment | 050065 | Complex | 11/2024 | No Change |
| Enfuvirtide | Subcutaneous | Injectable | 021481 | Complex | 11/2024 | Newly Added |
| Ensifentrine | Inhalation | Suspension | 217389 | Complex | 05/2025 | Newly Added |
| Epinephrine | Intravenous | Solution | 215875 | Non-Complex | 02/2025 | Newly Added |
| Eplontersen Sodium | Subcutaneous | Solution | 217388 | Complex | 11/2024 | No Change |
| Estrogens, Conjugated | Topical, Vaginal | Cream | 020216 | Complex | 11/2024 | Newly Added |
| Etrasimod Arginine | Oral | Tablet | 216956 | Non-Complex | 02/2025 | No Change |
| Flunisolide | Inhalation | Aerosol, Metered | 021247 | Complex | 08/2025 | Newly Added |
| Fluticasone Propionate | Nasal | Spray, Metered | 209022 | Complex | Within the next 12 months | Planned publication date change to an earlier date |
| Fruquintinib | Oral | Capsule | 217564 | Non-Complex | 05/2025 | No Change |
| Gepirone Hydrochloride | Oral | Tablet, Extended Release | 021164 | Non-Complex | Within the next 12 months | Planned publication date change to an earlier date |
| Givinostat Hydrochloride | Oral | Suspension | 217865 | Non-Complex | 08/2025 | Newly Added |
| Icatibant Acetate | Subcutaneous | Injectable | 022150 | Non-Complex | 11/2024 | No Change |
| Iptacopan Hydrochloride | Oral | Capsule | 218276 | Non-Complex | 05/2025 | Newly Added |
| Lanreotide Acetate | Subcutaneous | Solution | 215395 | Complex | Within the next 12 months | No change |
| Levonorgestrel | Intrauterine | Intrauterine Device | 208224 | Complex | Within 12 months | Planned publication date change to a later date |
| Lidocaine; Tetracaine | Topical | Patch | 021623 | Complex | Beyond 12 months | No Change |
| Macitentan; Tadalafil | Oral | Tablet | 218490 | Non-Complex | 11/2024 | Newly Added |
| Magnesium Sulfate; Polyethylene Glycol 3350; Potassium Chloride; Sodium Chloride; Sodium Sulfate | Oral | For Solution | 215344 | Complex | 11/2024 | No Change |
| Memantine Hydrochloride | Oral | Orally Disintegrating Tablet | 021487 Dosage Form is subject of an approved suitability petition (FDA-2007-P-0061) |
Non-Complex | 11/2024 | Newly Added |
| Mitomycin | Pyelocalyceal | Powder | 211728 | Complex | 11/2024 | No Change |
| Momelotinib Dihydrochloride | Oral | Tablet | 216873 | Non-Complex | 02/2025 | No Change |
| Mometasone Furoate | Implantation | Implant | 209310 | Complex | 02/2025 | No Change |
| Motixafortide Acetate | Subcutaneous | Powder | 217159 | Non-Complex | 02/2025 | Newly Added |
| Naloxone Hydrochloride | Nasal | Spray | 215487 | Complex | 05/2025 | Newly Added |
| Nirogacestat Hydrobromide | Oral | Tablet | 217677 | Non-Complex | 05/2025 | No Change |
| Paclitaxel | Intravenous | Powder | 216338 | Complex | 11/2024 | No Change |
| Paclitaxel | Intravenous | Powder | 211875 | Complex | 02/2025 | Newly Added |
| Palovarotene | Oral | Capsule | 215559 | Non-Complex | 11/2024 | No Change |
| Patiromer Sorbitex Calcium | Oral | Powder | 205739 | Complex | Within the next 12 months | No change |
| Pemetrexed Disodium | Intravenous | Solution | 215179 | Non-Complex | 11/2024 | No Change |
| Pemetrexed Disodium | Intravenous | Solution | 214218 | Non-Complex | 02/2025 | Newly Added |
| Pemetrexed Ditromethamine | Intravenous | Powder | 208746 | Non-Complex | 02/2025 | Newly Added |
| Phentolamine Mesylate | Ophthalmic | Solution | 217064 | Non-Complex | 11/2024 | No Change |
| Phytonadione | Injection | Injectable | 083722 | Non-Complex | 11/2024 | Newly Added |
| Phytonadione | Injection | Injectable | 087955, 087954 | Non-Complex | 11/2024 | Newly Added |
| Pilocarpine Hydrochloride | Ophthalmic | Solution | 217836 | Non-Complex | 02/2025 | Newly Added |
| Quizartinib Dihydrochloride | Oral | Tablet | 216993 | Non-Complex | 11/2024 | No Change |
| Repotrectinib | Oral | Capsule | 218213 | Non-Complex | 02/2025 | Planned publication date change to an earlier date |
| Resmetirom | Oral | Tablet | 217785 | Non-Complex | 08/2025 | Newly Added |
| Risperidone | Subcutaneous | Suspension, Extended Release | 213586 | Complex | 11/2024 | No Change |
| Ritlecitinib Tosylate | Oral | Capsule | 215830 | Non-Complex | 11/2024 | No Change |
| Roflumilast | Topical | Cream | 215985 | Complex | Within the next 12 months | No change |
| Tenapanor Hydrochloride | Oral | Tablet | 213931 | Complex | 08/2025 | Newly Added |
| Tovorafenib | Oral | For Suspension | 218033 | Non-Complex | 08/2025 | Newly Added |
| Treprostinil | Inhalation | Powder | 214324 | Complex | 11/2024 | No Change |
| Vamorolone | Oral | Suspension | 215239 | Non-Complex | 02/2025 | No Change |
| Zilucoplan Sodium | Subcutaneous | Solution | 216834 | Non-Complex | 02/2025 | Newly Added |
| Zuranolone | Oral | Capsule | 217369 | Non-Complex | 02/2025 | No Change |
Planned Revised PSGs for Complex and Non-Complex
Generic Drug Products
Updated August 22, 2024
| Active Ingredient(s) | Route Of Administration | Dosage Form | RLD or RS Application Number | Planned Revision Category with Description | Product Complexity | Planned Publication | Updates |
|---|---|---|---|---|---|---|---|
| Acetaminophen; Butalbital | Oral | Capsule | 088831 | Minor Revision: Remove recommendation on a strength due to safety concerns | Non-Complex | Within the next 12 months | No change |
| Aclidinium Bromide | Inhalation | Powder, Metered | 202450 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 08/2025 | Newly added |
| Aclidinium Bromide; Formoterol Fumarate | Inhalation | Powder, Metered | 210595 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 08/2025 | Newly added |
| Albuterol Sulfate | Inhalation | Powder, Metered | 205636 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 05/2025 | Newly added |
| Allopurinol | Oral | Tablet | 016084 | Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD/RS; Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 11/2024 | Revision description change |
| Azelaic Acid | Topical | Gel | 021470 | Minor Revision: Add an in vitro BE option | Complex | 11/2024 | Planned publication date change to a later date |
| Beclomethasone Dipropionate | Inhalation | Aerosol, Metered | 020911 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 08/2025 | Newly added |
| Beclomethasone Dipropionate | Inhalation | Aerosol, Metered | 207921 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 08/2025 | Newly added |
| Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate | Oral | Tablet | 210251 | Minor Revision: Add information on newly approved strength of the RLD (lower strength); Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 11/2024 | Revision description change |
| Budesonide; Formoterol Fumarate Dihydrate | Inhalation | Aerosol, Metered | 021929 | Minor Revision: Add an in vitro and in vivo BE option | Complex | 11/2024 | Planned publication date change to an earlier date |
| Ciclesonide | Inhalation | Aerosol, Metered | 021658 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 08/2025 | Newly added |
| Enzalutamide | Oral | Tablet | 213674 | In Vivo Major Revision: Add new higher strengths approved by suitability petition | Non-Complex | 11/2024 | Newly added |
| Epinephrine | Inhalation | Aerosol, Metered | 205920 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 02/2025 | Newly added |
| Ferric Carboxymaltose | Intravenous | Solution | 203565 | Minor Revision: Add an in vivo BE study option | Complex | 11/2024 | No change |
| Ferumoxytol | Intravenous | Solution | 022180 | Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances Minor Revision: Add an in vivo BE option |
Complex | 11/2024 | Revision description change |
| Fluorouracil | Topical | Cream | 020985 | Minor Revision: Add an in vitro BE option | Complex | Beyond 12 months | No change |
| Fluticasone Furoate | Inhalation | Powder | 205625 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 05/2025 | Newly added |
| Fluticasone Furoate; Vilanterol Trifenatate | Inhalation | Powder | 204275 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 05/2025 | Newly added |
| Fluticasone Propionate | Inhalation | Powder | 020833 | Minor Revision: Add an in vitro and in vivo BE option | Complex | 11/2024 | Newly added |
| Fluticasone Propionate; Salmeterol Xinafoate | Inhalation | Powder | 021077 | Minor Revision: Add an in vitro and in vivo BE option | Complex | 11/2024 | Newly added |
| Formoterol Fumarate | Inhalation | Powder | 020831 | Minor Revision: Add an in vitro and in vivo BE option | Complex | 11/2024 | No change |
| Formoterol Fumarate; Mometasone Furoate | Inhalation | Aerosol, Metered | 022518 | Minor Revision: Add an in vitro and in vivo BE option | Complex | 11/2024 | Planned publication date change to an earlier date |
| Glycopyrrolate | Inhalation | Powder | 207923 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 08/2025 | Newly added |
| Glycopyrrolate; Indacaterol Maleate | Inhalation | Powder | 207930 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 08/2025 | Newly added |
| Indacaterol Maleate | Inhalation | Powder | 022383 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 08/2025 | Newly added |
| Ipratropium Bromide | Inhalation | Aerosol, Metered | 021527 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 08/2025 | Newly added |
| Labetalol Hydrochloride | Oral | Tablet | 018687, 018716 | Minor Revision: Expand the eligibility for an in vitro-based BE option; Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 11/2024 | Revision description change |
| Lanreotide Acetate | Subcutaneous | Solution | 022074 | Editorial Revision: Update the language Minor Revision: Add recommendations for device comparisons |
Complex | Within the next 12 months | No change |
| Lenvatinib Mesylate | Oral | Capsule | 206947 |
In Vitro Major Revision: Add in vitro feeding tube studies Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex | 11/2024 | Revision description change |
| Levonorgestrel | Intrauterine | Intrauterine Device | 203159 | Minor Revision: Clarify in vivo and in vitro study designs; Add recommendations for device comparisons | Complex | 11/2024 | Planned publication date change to a later date |
| Liraglutide | Subcutaneous | Solution | 022341 | Editorial Revision: Update the language Minor Revision: Add recommendations for device comparisons |
Complex | 11/2024 | Newly added |
| Mometasone Furoate | Inhalation | Aerosol, Metered | 205641 | Minor Revision: Add an in vitro and in vivo BE option | Complex | 11/2024 | Planned publication date change to an earlier date |
| Nepafenac | Ophthalmic | Suspension/Drops | 021862 | Minor Revision: Clarify in vivo and in vitro study designs; Add recommendations for device comparisons | Complex | 11/2024 | Planned publication date change to a later date |
| Nepafenac | Ophthalmic | Suspension/Drops | 203491 | Minor Revision: Clarify in vivo and in vitro study designs; Add recommendations for device comparisons | Complex | 11/2024 | Planned publication date change to a later date |
| Nitroglycerin | Intra-Anal | Ointment | 021359 | Minor Revision: Remove recommendations on drug device combination product | Complex | 11/2024 | Newly added |
| Olaparib | Oral | Tablet | 208558 | Minor Revision: Clarify in vivo study design | Non-Complex | 11/2024 | No change |
| Phytonadione | Oral | Tablet | 010104 | Minor Revision: Change in study design for in vivo BE study(ies) | Non-Complex | 11/2024 | Newly added |
| Phytonadione | Injection | Injectable | 012223 | Minor: Add an in vitro BE option as an alternative BE approach | Non-Complex | 11/2024 | Newly added |
| Ruxolitinib Phosphate | Topical | Cream | 215309 | Editorial Revision: Correct Typos Minor Revision: Add an in vitro BE option |
Complex | 11/2024 | Newly added |
| Salmeterol Xinafoate | Inhalation | Powder | 020692 | Minor Revision: Add an in vitro and in vivo BE option | Complex | 11/2024 | No change |
| Tacrolimus | Topical | Ointment | 050777 | Minor Revision: Add an in vitro BE option | Complex | 11/2024 | Newly added |
| Tazarotene | Topical | Cream | 021184 | Minor Revision: Add an in vitro BE option | Complex | 11/2024 | Newly added |
| Tiotropium Bromide | Inhalation | Powder | 021395 | Minor Revision: Add an in vitro and in vivo BE option | Complex | 11/2024 | No change |
| Tramadol Hydrochloride | Oral | Tablet | 020281 |
In Vivo Major Revision: Change in study design for in vivo BE study(ies) (to add a new higher strength) Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex | 11/2024 | Revision description change |
| Umeclidinium Bromide | Inhalation | Powder | 205382 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 05/2025 | Newly added |
| Umeclidinium Bromide; Vilanterol Trifenatate | Inhalation | Powder | 203975 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 05/2025 | Newly added |
Planned Revised PSGs for Complex and Non-Complex Generic Drug Products to Align with ICH M13A
Updated September 13, 2024
In addition to removing the BE recommendations for BE studies under either fasting or fed conditions as indicated in the table, these PSGs may also include editorial revisions to language and formatting as deemed appropriate by the Agency.
| Active Ingredient(s) | Route of Administration | Dosage Form | RLD or RS Application Number | Planned Revision Category with Description | Product Complexity | Planned Publication |
|---|---|---|---|---|---|---|
| Abacavir Sulfate | Oral | Tablet | 020977 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Abacavir Sulfate; Dolutegravir Sodium; Lamivudine | Oral | Tablet | 205551 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Abacavir Sulfate; Dolutegravir Sodium; Lamivudine | Oral | Tablet, For Suspension | 215413 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Abacavir Sulfate; Lamivudine | Oral | Tablet | 021652 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Abacavir Sulfate; Lamivudine; Zidovudine | Oral | Tablet | 021205 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Abemaciclib | Oral | Tablet | 208716 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Abrocitinib | Oral | Tablet | 213871 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Acalabrutinib | Oral | Capsule | 210259 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Acetaminophen; Aspirin; Caffeine | Oral | Tablet | 020802 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Acetaminophen; Benzhydrocodone Hydrochloride | Oral | Tablet | 208653 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Acetaminophen; Butalbital; Caffeine; Codeine Phosphate | Oral | Capsule | 020232 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Acetaminophen; Ibuprofen | Oral | Tablet | 211733 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Acetaminophen; Propoxyphene Napsylate | Oral | Tablet | 017122 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Acetaminophen; Tramadol Hydrochloride | Oral | Tablet | 021123 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Acetazolamide | Oral | Tablet | 008943 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Acetylcysteine | Oral | Tablet, Effervescent | 207916 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Acrivastine; Pseudoephedrine Hydrochloride | Oral | Capsule | 019806 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Acyclovir | Oral | Capsule | 018828 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Acyclovir | Oral | Suspension | 019909 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Acyclovir | Oral | Tablet | 020089 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Adagrasib | Oral | Tablet | 216340 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Adefovir Dipivoxil | Oral | Tablet | 021449 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Albuterol Sulfate | Oral | Tablet | 017853 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Allopurinol; Lesinurad | Oral | Tablet | 209203 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Almotriptan Malate | Oral | Tablet | 021001 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Alogliptin Benzoate | Oral | Tablet | 022271 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Alogliptin Benzoate; Metformin Hydrochloride | Oral | Tablet | 203414 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Alogliptin Benzoate; Pioglitazone Hydrochloride | Oral | Tablet | 022426 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Alosetron Hydrochloride | Oral | Tablet | 021107 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Alprazolam | Oral | Tablet | 018276 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Alprazolam | Oral | Tablet, Orally Disintegrating | 021726 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amantadine Hydrochloride | Oral | Capsule | 016020 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amantadine Hydrochloride | Oral | Tablet | 018101 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ambrisentan | Oral | Tablet | 022081 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amifampridine Phosphate | Oral | Tablet | 208078 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amiloride Hydrochloride | Oral | Tablet | 018200 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Aminocaproic Acid | Oral | Tablet | 015197 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amiodarone Hydrochloride | Oral | Tablet | 018972 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amitriptyline Hydrochloride | Oral | Tablet | 012703 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amitriptyline Hydrochloride; Chlordiazepoxide | Oral | Tablet | 016949 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amlodipine Benzoate | Oral | Suspension | 211340 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amlodipine Besylate | Oral | Tablet | 019787 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amlodipine Besylate; Atorvastatin Calcium | Oral | Tablet | 021540 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amlodipine Besylate; Benazepril Hydrochloride | Oral | Capsule | 020364 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amlodipine Besylate; Celecoxib | Oral | Tablet | 210045 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil | Oral | Tablet | 200175 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amlodipine Besylate; Hydrochlorothiazide; Valsartan | Oral | Tablet | 022314 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amlodipine Besylate; Olmesartan Medoxomil | Oral | Tablet | 022100 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amlodipine Besylate; Perindopril Arginine | Oral | Tablet | 205003 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amlodipine Besylate; Valsartan | Oral | Tablet | 021990 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amoxicillin | Oral | Capsule | 050459 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amoxicillin | Oral | For Suspension | 050460 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amoxicillin | Oral | Tablet, Chewable | 050542 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amoxicillin | Oral | For Suspension | 050760 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amoxicillin; Clarithromycin; Vonoprazan Fumarate | Oral | Capsule, Tablet, Tablet | 215152 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amoxicillin; Clavulanate Potassium | Oral | For Suspension | 050575 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amoxicillin; Clavulanate Potassium | Oral | Tablet, Chewable | 050597 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amoxicillin; Clavulanate Potassium | Oral | Tablet, Chewable | 050726 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amoxicillin; Clavulanate Potassium | Oral | Tablet | 050564; 050720 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amoxicillin; Clavulanate Potassium | Oral | For Suspension | 050725; 050755 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amoxicillin; Vonoprazan Fumarate | Oral | Capsule, Tablet | 215153 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Oral | Tablet | 011522 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Anagrelide Hydrochloride | Oral | Capsule | 020333 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Anastrozole | Oral | Tablet | 020541 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Apixaban | Oral | Tablet | 202155 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Apremilast | Oral | Tablet | 205437 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Aripiprazole | Oral | Tablet | 021436 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Aripiprazole | Oral | Tablet, Orally Disintegrating | 021729 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Armodafinil | Oral | Tablet | 021875 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Aspirin | Oral | Capsule | 203697 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Aspirin; Butalbital; Caffeine; Codeine Phosphate | Oral | Capsule | 019429 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Atazanavir Sulfate | Oral | Capsule | 021567 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Atazanavir Sulfate; Cobicistat | Oral | Tablet | 206353 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Atenolol | Oral | Tablet | 018240 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Atenolol; Chlorthalidone | Oral | Tablet | 018760 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Atomoxetine Hydrochloride | Oral | Capsule | 021411 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Atorvastatin Calcium | Oral | Tablet | 020702 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Atorvastatin Calcium | Oral | Suspension | 213260 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Atorvastatin Calcium; Ezetimibe | Oral | Tablet | 200153 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Atovaquone | Oral | Tablet | 020259 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Atovaquone | Oral | Suspension | 020500 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Auranofin | Oral | Capsule | 018689 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Avanafil | Oral | Tablet | 202276 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Avatrombopag Maleate | Oral | Tablet | 210238 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Axitinib | Oral | Tablet | 202324 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Azilsartan Kamedoxomil | Oral | Tablet | 200796 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Azilsartan Kamedoxomil; Chlorthalidone | Oral | Tablet | 202331 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Azithromycin | Oral | For Suspension | 050693 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Azithromycin | Oral | For Suspension | 050710 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Azithromycin | Oral | Tablet | 050711; 050730; 050784 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Baclofen | Oral | Tablet | 017851 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Baclofen | Oral | Tablet, Orally Disintegrating | 021589 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Baclofen | Oral | Granules | 215422 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Baclofen | Oral | Suspension | 215602 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Baloxavir Marboxil | Oral | Tablet | 210854 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Baloxavir Marboxil | Oral | For Suspension | 214410 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Baricitinib | Oral | Tablet | 207924 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Bedaquiline Fumarate | Oral | Tablet | 204384 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Belumosudil Mesylate | Oral | Tablet | 214783 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Bempedoic Acid | Oral | Tablet | 211616 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Bempedoic Acid; Ezetimibe | Oral | Tablet | 211617 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Benazepril Hydrochloride | Oral | Tablet | 019851 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Benazepril Hydrochloride; Hydrochlorothiazide | Oral | Tablet | 020033 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Benznidazole | Oral | Tablet | 209570 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Berotralstat Hydrochloride | Oral | Capsule | 214094 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Bexagliflozin | Oral | Tablet | 214373 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Bicalutamide | Oral | Tablet | 020498 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Binimetinib | Oral | Tablet | 210498 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Bisoprolol Fumarate | Oral | Tablet | 019982 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Bisoprolol Fumarate; Hydrochlorothiazide | Oral | Tablet | 020186 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Boceprevir | Oral | Capsule | 202258 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Bosentan | Oral | Tablet | 021290 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Bosentan | Oral | Tablet, For Suspension | 209279 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Bosutinib Monohydrate | Oral | Tablet | 203341 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Brexpiprazole | Oral | Tablet | 205422 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Brincidofovir | Oral | Tablet | 214461 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Brivaracetam | Oral | Tablet | 205836 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Bumetanide | Oral | Tablet | 018225 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Bupropion Hydrochloride | Oral | Tablet | 018644 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Buspirone Hydrochloride | Oral | Tablet | 018731 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cabotegravir Sodium | Oral | Tablet | 212887 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Calcium Carbonate; Famotidine; Magnesium Hydroxide | Oral | Tablet, Chewable | 020958 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Canagliflozin | Oral | Tablet | 204042 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Canagliflozin; Metformin Hydrochloride | Oral | Tablet | 204353 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Candesartan Cilexetil | Oral | Tablet | 020838 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Candesartan Cilexetil; Hydrochlorothiazide | Oral | Tablet | 021093 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Capmatinib Hydrochloride | Oral | Tablet | 213591 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Carbidopa | Oral | Tablet | 017830 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Carbidopa; Entacapone; Levodopa | Oral | Tablet | 021485 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Carbidopa; Levodopa | Oral | Tablet | 017555 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Carbidopa; Levodopa | Oral | Tablet, Orally Disintegrating | 078690 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Carglumic Acid | Oral | Tablet, For Suspension | 022562 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cariprazine Hydrochloride | Oral | Capsule | 204370 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Carisoprodol | Oral | Tablet | 011792 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Carvedilol | Oral | Tablet | 020297 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cefaclor | Oral | Capsule | 050521 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cefadroxil/Cefadroxil Hemihydrate | Oral | Capsule | 050512 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cefdinir | Oral | Capsule | 050739 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cefdinir | Oral | For Suspension | 050749 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cefditoren Pivoxil | Oral | Tablet | 021222 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cefixime | Oral | Tablet | 050621 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cefixime | Oral | Tablet, Chewable | 065380 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cefixime | Oral | Capsule | 203195 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cefixime | Oral | For Suspension | 050622; 202091 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cefpodoxime Proxetil | Oral | For Suspension | 050674 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cefpodoxime Proxetil | Oral | Tablet | 050675 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cefprozil | Oral | Tablet | 050664 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cefprozil | Oral | For Suspension | 050665 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cefuroxime Axetil | Oral | Tablet | 050605 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cefuroxime Axetil | Oral | For Suspension | 050672 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Celecoxib | Oral | Capsule | 020998 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 02/2025 |
| Celecoxib; Tramadol Hydrochloride | Oral | Tablet | 213426 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cenobamate | Oral | Tablet | 212839 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cephalexin | Oral | Capsule | 050405 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cephalexin | Oral | For Suspension | 050406 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ceritinib | Oral | Capsule | 205755 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ceritinib | Oral | Tablet | 211225 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cetirizine Hydrochloride | Oral | Tablet | 019835 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cetirizine Hydrochloride | Oral | Tablet, Chewable | 021621 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cetirizine Hydrochloride | Oral | Capsule | 022429 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cetirizine Hydrochloride | Oral | Tablet, Orally Disintegrating | 022578 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cevimeline Hydrochloride | Oral | Capsule | 020989 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Chenodiol | Oral | Tablet | 018513 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Chlordiazepoxide Hydrochloride | Oral | Capsule | 012249 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Chlordiazepoxide Hydrochloride; Clidinium Bromide | Oral | Capsule | 012750 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Chlorothiazide | Oral | Suspension | 011870 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Chlorpheniramine Maleate; Ibuprofen; Phenylephrine Hydrochloride | Oral | Tablet | 022113 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Chlorpheniramine Maleate; Ibuprofen; Pseudoephedrine Hydrochloride | Oral | Tablet | 021441 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Chlorpromazine Hydrochloride | Oral | Tablet | 084112; 084114 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Chlorthalidone | Oral | Tablet | 012283 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Chlorthalidone | Oral | Tablet | 019574 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Chlorzoxazone | Oral | Tablet | 011529 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cholic Acid | Oral | Capsule | 205750 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cimetidine | Oral | Tablet | 017920 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cinacalcet Hydrochloride | Oral | Tablet | 021688 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ciprofloxacin | Oral | For Suspension | 020780 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ciprofloxacin Hydrochloride | Oral | Tablet | 019537 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Citalopram Hydrobromide | Oral | Tablet | 020822 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Citalopram Hydrobromide | Oral | Capsule | 077668 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Citalopram Hydrobromide | Oral | Capsule | 215428 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Clarithromycin | Oral | Tablet | 050662 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Clarithromycin | Oral | For Suspension | 050698 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Clemastine Fumarate | Oral | Tablet | 017661 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Clemastine Fumarate | Oral | Tablet | 020925 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Clindamycin Hydrochloride | Oral | Capsule | 050162 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Clobazam | Oral | Tablet | 202067 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Clobazam | Oral | Suspension | 203993 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Clomiphene Citrate | Oral | Tablet | 016131 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Clomipramine Hydrochloride | Oral | Capsule | 019906 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Clonazepam | Oral | Tablet | 017533 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Clonazepam | Oral | Tablet, Orally Disintegrating | 020813 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Clonidine Hydrochloride | Oral | Tablet | 017407 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Clopidogrel Bisulfate | Oral | Tablet | 020839 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Clorazepate Dipotassium | Oral | Tablet | 017105 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cobicistat | Oral | Tablet | 203094 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cobimetinib Fumarate | Oral | Tablet | 206192 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Colchicine | Oral | Tablet | 022352 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Colchicine | Oral | Capsule | 204820 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Crizotinib | Oral | Capsule | 202570 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cyclobenzaprine Hydrochloride | Oral | Tablet | 017821 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Cycloserine | Oral | Capsule | 060593 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Daclatasvir Dihydrochloride | Oral | Tablet | 206843 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Dacomitinib | Oral | Tablet | 211288 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Dantrolene Sodium | Oral | Capsule | 017443 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Dapagliflozin | Oral | Tablet | 202293 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Dapagliflozin; Saxagliptin Hydrochloride | Oral | Tablet | 209091 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Daprodustat | Oral | Tablet | 216951 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Dapsone | Oral | Tablet | 086841; 086842 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Daridorexant Hydrochloride | Oral | Tablet | 214985 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 02/2025 |
| Darolutamide | Oral | Tablet | 212099 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Darunavir | Oral | Tablet | 021976 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Darunavir | Oral | Suspension | 202895 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Dasatinib | Oral | Tablet | 021986 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Deferiprone | Oral | Tablet | 021825 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Deflazacort | Oral | Tablet | 208684 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Deflazacort | Oral | Suspension | 208685 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Delafloxacin Meglumine | Oral | Tablet | 208610 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Delavirdine Mesylate | Oral | Tablet | 020705 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Desipramine Hydrochloride | Oral | Tablet | 014399 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Desloratadine | Oral | Tablet | 021165 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Desloratadine | Oral | Tablet, Orally Disintegrating | 021312 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Desmopressin Acetate | Oral | Tablet | 019955 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Desogestrel; Ethinyl Estradiol | Oral-28 | Tablet | 020301 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Desogestrel; Ethinyl Estradiol | Oral-28 | Tablet | 020713 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Desogestrel; Ethinyl Estradiol | Oral-21 | Tablet | 021090 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Dexamethasone | Oral | Tablet | 011664 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Dexmethylphenidate Hydrochloride | Oral | Tablet | 021278 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Dexmethylphenidate Hydrochloride; Serdexmethylphenidate Chloride | Oral | Capsule | 212994 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Dextromethorphan Hydrobromide; Quinidine Sulfate | Oral | Capsule | 021879 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Diazepam | Oral | Tablet | 013263 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Diazoxide | Oral | Suspension | 017453 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Dichlorphenamide | Oral | Tablet | 011366 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Diclofenac | Oral | Capsule | 204592 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Diclofenac Potassium | Oral | Tablet | 020142 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Diclofenac Potassium | Oral | Capsule | 022202 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Dicyclomine Hydrochloride | Oral | Capsule | 007409 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Dicyclomine Hydrochloride | Oral | Tablet | 007409 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Dienogest; Estradiol Valerate | Oral | Tablet | 022252 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Diflunisal | Oral | Tablet | 018445 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Diphenhydramine Citrate; Ibuprofen | Oral | Tablet | 021394 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Diphenhydramine Hydrochloride | Oral | Capsule | 080738 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Diphenhydramine Hydrochloride; Ibuprofen | Oral | Capsule | 021393 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Diphenhydramine Hydrochloride; Naproxen Sodium | Oral | Tablet | 205352 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Dipyridamole | Oral | Tablet | 012836 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Disopyramide Phosphate | Oral | Capsule | 017447 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Disulfiram | Oral | Tablet | 007883 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Dofetilide | Oral | Capsule | 020931 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Dolasetron Mesylate | Oral | Tablet | 020623 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Dolutegravir Sodium | Oral | Tablet | 204790 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Dolutegravir Sodium | Oral | Tablet, For Suspension | 213983 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Dolutegravir Sodium; Lamivudine | Oral | Tablet | 211994 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Dolutegravir Sodium; Rilpivirine Hydrochloride | Oral | Tablet | 210192 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Donepezil Hydrochloride | Oral | Tablet | 020690 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Donepezil Hydrochloride | Oral | Tablet, Orally Disintegrating | 021720 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Donepezil Hydrochloride | Oral | Tablet | 022568 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Doxazosin Mesylate | Oral | Tablet | 019668 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Doxepin Hydrochloride | Oral | Capsule | 016798 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Doxepin Hydrochloride | Oral | Tablet | 022036 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Doxycycline | Oral | Capsule | 065055 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Doxycycline | Oral | Capsule | 065070 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Doxycycline | Oral | Tablet | 065055 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Doxycycline | Oral | For Suspension | 050006 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Doxycycline Calcium | Oral | Suspension | 050480 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Doxycycline Hyclate | Oral | Capsule | 050007 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Doxycycline Hyclate | Oral | Tablet | 050533 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Doxycycline Hyclate | Oral | Tablet | 205931 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Doxycycline Hyclate | Oral | Capsule | 209844 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Doxycycline Hyclate | Oral | Tablet | 208253 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Dronedarone Hydrochloride | Oral | Tablet | 022425 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Drospirenone | Oral | Tablet | 211367 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Drospirenone; Estetrol | Oral | Tablet | 214154 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Drospirenone; Estradiol | Oral | Tablet | 021355 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Drospirenone; Ethinyl Estradiol | Oral-28 | Tablet | 021098 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Drospirenone; Ethinyl Estradiol | Oral | Tablet | 021676 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Drospirenone; Ethinyl Estradiol; Levomefolate Calcium | Oral | Tablet | 022532; 022574 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Droxidopa | Oral | Capsule | 203202 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Duvelisib | Oral | Capsule | 211155 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Elacestrant Dihydrochloride | Oral | Tablet | 217639 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Elagolix Sodium | Oral | Tablet | 210450 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 02/2025 |
| Elagolix Sodium, Estradiol, Norethindrone Acetate; Elagolix Sodium | Oral | Capsule | 213388 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 02/2025 |
| Eletriptan Hydrobromide | Oral | Tablet | 021016 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Eliglustat Tartrate | Oral | Capsule | 205494 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Eltrombopag Olamine | Oral | Tablet | 022291 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Eltrombopag Olamine | Oral | For Suspension | 207027 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Eluxadoline | Oral | Tablet | 206940 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Empagliflozin | Oral | Tablet | 204629 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Empagliflozin; Linagliptin | Oral | Tablet | 206073 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Empagliflozin; Metformin Hydrochloride | Oral | Tablet | 206111 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Emtricitabine | Oral | Capsule | 021500 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Alafenamide Fumarate | Oral | Tablet | 208351 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Disoproxil Fumarate | Oral | Tablet | 202123 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Emtricitabine; Tenofovir Alafenamide Fumarate | Oral | Tablet | 208215 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Emtricitabine; Tenofovir Disoproxil Fumarate | Oral | Tablet | 021752 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Enalapril Maleate | Oral | Tablet | 018998 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Enasidenib Mesylate | Oral | Tablet | 209606 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Entacapone | Oral | Tablet | 020796 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Eplerenone | Oral | Tablet | 021437 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Eprosartan Mesylate | Oral | Tablet | 020738 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Eprosartan Mesylate; Hydrochlorothiazide | Oral | Tablet | 021268 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Erdafitinib | Oral | Tablet | 212018 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ertugliflozin | Oral | Tablet | 209803 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 02/2025 |
| Ertugliflozin; Metformin Hydrochloride | Oral | Tablet | 209806 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ertugliflozin; Sitagliptin Phosphate | Oral | Tablet | 209805 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Erythromycin Ethylsuccinate | Oral | Granule | 050207 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Erythromycin Ethylsuccinate | Oral | Tablet | 061904; 061905 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Erythromycin Ethylsuccinate; Sulfisoxazole Acetyl | Oral | Granule | 050529 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Escitalopram Oxalate | Oral | Capsule | 021323 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Escitalopram Oxalate | Oral | Tablet | 077660 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Eslicarbazepine Acetate | Oral | Tablet | 022416 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Estradiol | Oral | Tablet | 084499; 084500 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Estradiol; Norethindrone Acetate | Oral | Tablet | 020907 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Estrogens, Esterified | Oral | Tablet | 083266 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Eszopiclone | Oral | Tablet | 021476 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ethacrynic Acid | Oral | Tablet | 016092 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ethambutol Hydrochloride | Oral | Tablet | 016320 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ethinyl Estradiol; Ethynodiol Diacetate | Oral-21 | Tablet | 072723 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ethinyl Estradiol; Norethindrone Acetate | Oral | Tablet, Chewable | 204654 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ethinyl Estradiol; Levonorgestrel | Oral-21 | Tablet | 020683 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ethinyl Estradiol; Levonorgestrel | Oral | Tablet | 020860 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ethinyl Estradiol; Levonorgestrel | Oral | Tablet | 021864 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ethinyl Estradiol; Levonorgestrel | Oral-21 | Tablet | 208612 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ethinyl Estradiol; Levonorgestrel | Oral-21 | Tablet | 019190; 019192 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ethinyl Estradiol; Levonorgestrel | Oral | Tablet | 018782 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ethinyl Estradiol; Levonorgestrel | Oral-21 | Tablet | 021544; 021840; 204061 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ethinyl Estradiol; Norethindrone | Oral | Tablet | 018977 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ethinyl Estradiol; Norethindrone | Oral | Tablet | 021490, 202086 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ethinyl Estradiol; Norethindrone | Oral-28 | Tablet, Chewable | 022573 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ethinyl Estradiol; Norethindrone | Oral-28 | Tablet | 017716; 200897; 203006 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ethinyl Estradiol; Norethindrone Acetate | Oral | Tablet | 017354; 017355; 021871 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ethinyl Estradiol; Norethindrone | Oral-21 | Tablet | 017735; 017919; 018985 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ethinyl Estradiol; Norethindrone Acetate | Oral-21 | Tablet | 020130 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ethinyl Estradiol; Norethindrone Acetate | Oral | Tablet | 021065 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ethinyl Estradiol; Norethindrone Acetate | Oral | Tablet | 022501 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ethinyl Estradiol; Norethindrone Acetate | Oral | Tablet | 203667 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ethinyl Estradiol; Norgestimate | Oral-21 | Tablet | 019653; 019697; 021241 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ethinyl Estradiol; Norgestrel | Oral-21 | Tablet | 017612; 017802 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ethionamide | Oral | Tablet | 013026 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ethosuximide | Oral | Capsule | 012380 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Etodolac | Oral | Capsule | 018922 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Etodolac | Oral | Tablet | 018922 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Exemestane | Oral | Tablet | 020753 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ezetimibe | Oral | Tablet | 021445 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ezetimibe; Simvastatin | Oral | Tablet | 021687 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ezogabine | Oral | Tablet | 022345 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Famciclovir | Oral | Tablet | 020363 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Famotidine | Oral | For Suspension | 019527 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Famotidine | Oral | Tablet, Chewable | 020801 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Famotidine | Oral | Tablet | 019462; 020325 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Famotidine | Oral | Tablet, Orally Disintegrating | 020752; 021712 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Famotidine; Ibuprofen | Oral | Tablet | 022519 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Febuxostat | Oral | Tablet | 021856 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Fedratinib Hydrochloride | Oral | Capsule | 212327 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Fenofibric Acid | Oral | Tablet | 022418 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Fenoprofen Calcium | Oral | Capsule | 017604 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Fexofenadine Hydrochloride | Oral | Capsule | 020625 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Fexofenadine Hydrochloride | Oral | Tablet | 020872 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Fexofenadine Hydrochloride | Oral | Suspension | 021963 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Fexofenadine Hydrochloride | Oral | Suspension | 201373 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Finasteride | Oral | Tablet | 020180; 020788 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Finerenone | Oral | Tablet | 215341 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Fingolimod Hydrochloride | Oral | Capsule | 022527 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Fingolimod Lauryl Sulfate | Oral | Tablet, Orally Disintegrating | 214962 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Flavoxate Hydrochloride | Oral | Tablet | 016769 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Flecainide Acetate | Oral | Tablet | 018830 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Flibanserin | Oral | Tablet | 022526 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Fluconazole | Oral | Tablet | 019949 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Flucytosine | Oral | Capsule | 017001 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Fludrocortisone Acetate | Oral | Tablet | 010060 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Fluoxetine Hydrochloride | Oral | Capsule | 018936 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Fluoxetine Hydrochloride | Oral | Tablet | 020974 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Fluoxetine Hydrochloride | Oral | Tablet | 021860 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Fluoxetine Hydrochloride | Oral | Tablet | 202133 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Fluoxetine Hydrochloride; Olanzapine | Oral | Capsule | 021520 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Fluphenazine Hydrochloride | Oral | Tablet | 011751 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Flutamide | Oral | Capsule | 018554 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Fluvastatin Sodium | Oral | Capsule | 020261 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Fosamprenavir Calcium | Oral | Tablet | 021548 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Fosinopril Sodium | Oral | Tablet | 019915 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Fosinopril Sodium; Hydrochlorothiazide | Oral | Tablet | 020286 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Frovatriptan Succinate | Oral | Tablet | 021006 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Furosemide | Oral | Tablet | 016273 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Futibatinib | Oral | Tablet | 214801 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Gabapentin | Oral | Capsule | 020235 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Gabapentin | Oral | Tablet | 020882 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Galantamine Hydrobromide | Oral | Tablet | 021169 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ganaxolone | Oral | Suspension | 215904 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ganciclovir | Oral | Capsule | 020460 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Gefitinib | Oral | Tablet | 206995 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Gemifloxacin Mesylate | Oral | Tablet | 021158 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Gilteritinib Fumarate | Oral | Tablet | 211349 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Glasdegib Maleate | Oral | Tablet | 210656 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Glimepiride | Oral | Tablet | 020496 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Glimepiride; Pioglitazone Hydrochloride | Oral | Tablet | 021925 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Glimepiride; Rosiglitazone Maleate | Oral | Tablet | 021700 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Glipizide | Oral | Tablet | 017783 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Glipizide; Metformin Hydrochloride | Oral | Tablet | 021460 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Glyburide | Oral | Tablet | 020051 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Glyburide | Oral | Tablet | 017498; 017532 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Glyburide; Metformin Hydrochloride | Oral | Tablet | 021178 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Granisetron Hydrochloride | Oral | Tablet | 020305 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Griseofulvin, Microcrystalline | Oral | Tablet | 062279 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Guanfacine Hydrochloride | Oral | Tablet | 019032 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Haloperidol | Oral | Tablet | 015921 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Hydralazine Hydrochloride; Isosorbide Dinitrate | Oral | Tablet | 020727 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Hydrochlorothiazide | Oral | Tablet | 011835 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Hydrochlorothiazide | Oral | Capsule | 020504 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Hydrochlorothiazide; Irbesartan | Oral | Tablet | 020758 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Hydrochlorothiazide; Lisinopril | Oral | Tablet | 019778; 019888 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Hydrochlorothiazide; Losartan Potassium | Oral | Tablet | 020387 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Hydrochlorothiazide; Metoprolol Tartrate | Oral | Tablet | 018303 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Hydrochlorothiazide; Olmesartan Medoxomil | Oral | Tablet | 021532 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Hydrochlorothiazide; Quinapril Hydrochloride | Oral | Tablet | 020125 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Hydrochlorothiazide; Spironolactone | Oral | Tablet | 012616 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Hydrochlorothiazide; Triamterene | Oral | Capsule | 016042 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Hydrochlorothiazide; Triamterene | Oral | Tablet | 019129 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Hydrochlorothiazide; Valsartan | Oral | Tablet | 020818 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Hydrocodone Bitartrate; Ibuprofen | Oral | Tablet | 020716 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Hydrocortisone | Oral | Tablet | 008697 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Hydromorphone Hydrochloride | Oral | Tablet | 019892 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Hydroxychloroquine Sulfate | Oral | Tablet | 009768 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Hydroxyzine Pamoate | Oral | Capsule | 011459 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Hydroxyzine Pamoate | Oral | Suspension | 011795 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ibrexafungerp Citrate | Oral | Tablet | 214900 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ibrutinib | Oral | Capsule | 205552 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ibrutinib | Oral | Tablet | 210563 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ibuprofen | Oral | Tablet | 017463 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ibuprofen | Oral | Tablet | 019012 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ibuprofen | Oral | Suspension | 019842 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ibuprofen | Oral | Capsule | 020402 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ibuprofen | Oral | Suspension | 020516 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ibuprofen | Oral | Tablet, Chewable | 020601 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ibuprofen | Oral | Suspension/Drops | 020812 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ibuprofen | Oral | Capsule | 021472 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ibuprofen Sodium | Oral | Tablet | 201803 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ibuprofen; Phenylephrine Hydrochloride | Oral | Tablet | 022565 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ibuprofen; Pseudoephedrine Hydrochloride | Oral | Tablet | 019771 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ibuprofen; Pseudoephedrine Hydrochloride | Oral | Suspension | 021128 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ibuprofen; Pseudoephedrine Hydrochloride | Oral | Capsule | 021374 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Icosapent Ethyl | Oral | Capsule | 202057 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Complex | 10/2024 |
| Idelalisib | Oral | Tablet | 205858 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Iloperidone | Oral | Tablet | 022192 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Imipramine Pamoate | Oral | Capsule | 017090 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Indapamide | Oral | Tablet | 018538 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Indinavir Sulfate | Oral | Capsule | 020685 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Indomethacin | Oral | Capsule | 016059 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Indomethacin | Oral | Suspension | 018332 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Indomethacin | Oral | Capsule | 204768 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Irbesartan | Oral | Tablet | 020757 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Isavuconazonium Sulfate | Oral | Capsule | 207500 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Isocarboxazid | Oral | Tablet | 011961 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Isosorbide Dinitrate | Oral | Tablet | 012093 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Isosorbide Dinitrate | Oral | Tablet | 087946 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Isradipine | Oral | Capsule | 019546 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Istradefylline | Oral | Tablet | 022075 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ivabradine Hydrochloride | Oral | Tablet | 206143 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ketoconazole | Oral | Tablet | 018533 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ketoprofen | Oral | Capsule | 018754 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ketorolac Tromethamine | Oral | Tablet | 019645 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Lacosamide | Oral | Tablet | 022253 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Lamivudine | Oral | Tablet | 020564 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Lamivudine | Oral | Tablet | 021003 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Lamivudine; Tenofovir Disoproxil Fumarate | Oral | Tablet | 022141 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Lamivudine; Tenofovir Disoproxil Fumarate | Oral | Tablet | 022344 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Lamivudine; Tenofovir Disoproxil Fumarate | Oral | Tablet | 211284 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Lamivudine; Zidovudine | Oral | Tablet | 020857 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Lamotrigine | Oral | Tablet | 020241 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Lamotrigine | Oral | Tablet, Chewable | 020764 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Lamotrigine | Oral | Tablet, Orally Disintegrating | 022251 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Larotrectinib Sulfate | Oral | Capsule | 210861 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Lasmiditan Succinate | Oral | Tablet | 211280 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Leflunomide | Oral | Tablet | 020905 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Lemborexant | Oral | Tablet | 212028 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Lenalidomide | Oral | Capsule | 021880 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Lesinurad | Oral | Tablet | 207988 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Letermovir | Oral | Tablet | 209939 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Letrozole | Oral | Tablet | 020726 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Letrozole; Ribociclib Succinate | Oral | Tablet, Tablet | 209935 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Leucovorin Calcium | Oral | Tablet | 018342 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Levetiracetam | Oral | Tablet | 021035 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Levetiracetam | Oral | Tablet, For Suspension | 207958 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Levocarnitine | Oral | Tablet | 018948 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Levocetirizine Dihydrochloride | Oral | Tablet | 022064 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Levocetirizine Dihydrochloride | Oral | Tablet | 209089 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Levofloxacin | Oral | Tablet | 020634 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Levonorgestrel | Oral | Tablet | 021045; 021998 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Levorphanol Tartrate | Oral | Tablet | 008720 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Linagliptin | Oral | Tablet | 201280 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Linagliptin; Metformin Hydrochloride | Oral | Tablet | 201281 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Linezolid | Oral | Tablet | 021130 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Linezolid | Oral | For Suspension | 021132 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Lisdexamfetamine Dimesylate | Oral | Capsule | 021977 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Lisdexamfetamine Dimesylate | Oral | Tablet, Chewable | 208510 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Lisinopril | Oral | Tablet | 019777 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Lofexidine Hydrochloride | Oral | Tablet | 209229 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Loperamide Hydrochloride | Oral | Capsule | 017694 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Loperamide Hydrochloride | Oral | Suspension | 019487 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Loperamide Hydrochloride | Oral | Tablet | 019860 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Loperamide Hydrochloride | Oral | Tablet, Chewable | 020448 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Loperamide Hydrochloride | Oral | Capsule | 021855 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Loperamide Hydrochloride; Simethicone | Oral | Tablet, Chewable | 020606 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Loratadine | Oral | Tablet | 019658 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Loratadine | Oral | Tablet, Orally Disintegrating | 020704 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Loratadine | Oral | Tablet, Chewable | 021891 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Loratadine | Oral | Capsule | 21952 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 02/2025 |
| Lorazepam | Oral | Tablet | 017794 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Losartan Potassium | Oral | Tablet | 020386 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 11/2024 |
| Lumateperone Tosylate | Oral | Capsule | 209500 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Lurasidone Hydrochloride | Oral | Tablet | 200603 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Lusutrombopag | Oral | Tablet | 210923 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Macitentan | Oral | Tablet | 204410 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Maraviroc | Oral | Tablet | 022128 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Maribavir | Oral | Tablet | 215596 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Mavacamten | Oral | Capsule | 214998 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Mecamylamine Hydrochloride | Oral | Tablet | 010251 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Medroxyprogesterone Acetate | Oral | Tablet | 011839 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Mefenamic Acid | Oral | Capsule | 015034 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Megestrol Acetate | Oral | Suspension | 020264 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Meloxicam | Oral | Tablet | 020938 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Meloxicam | Oral | Suspension | 021530 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Meloxicam | Oral | Capsule | 207233 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Meloxicam | Oral | Tablet, Orally Disintegrating | 211210 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Memantine Hydrochloride | Oral | Tablet | 021487 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Mesna | Oral | Tablet | 020855 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Mestranol; Norethindrone | Oral-28 | Tablet | 016659 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Metformin Hydrochloride | Oral | Tablet | 020357 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Metformin Hydrochloride; Pioglitazone Hydrochloride | Oral | Tablet | 021842 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Metformin Hydrochloride; Repaglinide | Oral | Tablet | 022386 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Metformin Hydrochloride; Sitagliptin Phosphate | Oral | Tablet | 022044 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Methazolamide | Oral | Tablet | 011721 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Methenamine Hippurate | Oral | Tablet | 017681 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Methimazole | Oral | Tablet | 007517 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Methoxsalen | Oral | Capsule | 009048 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Methoxsalen | Oral | Capsule | 019600 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Methsuximide | Oral | Capsule | 010596 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Methylergonovine Maleate | Oral | Tablet | 006035 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Methylphenidate Hydrochloride | Oral | Tablet | 010187 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Methylphenidate Hydrochloride | Oral | Tablet, Chewable | 021475 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Methylprednisolone | Oral | Tablet | 011153 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Methyltestosterone | Oral | Capsule | 083976 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Metoclopramide Hydrochloride | Oral | Tablet | 017854 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Metoclopramide Hydrochloride | Oral | Tablet, Orally Disintegrating | 022246 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Metolazone | Oral | Tablet | 017386 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Metoprolol Tartrate | Oral | Tablet | 017963 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Metyrosine | Oral | Capsule | 017871 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Mexiletine Hydrochloride | Oral | Capsule | 018873 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Midodrine Hydrochloride | Oral | Tablet | 019815 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Miglustat | Oral | Capsule | 021348 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Milnacipran Hydrochloride | Oral | Tablet | 022256 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Minocycline Hydrochloride | Oral | Tablet | 050451 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Minocycline Hydrochloride | Oral | Capsule | 050649 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Minoxidil | Oral | Tablet | 018154 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Mirtazapine | Oral | Tablet | 020415 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Mirtazapine | Oral | Tablet, Orally Disintegrating | 021208 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Mitapivat Sulfate | Oral | Tablet | 216196 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Modafinil | Oral | Tablet | 020717 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Molindone Hydrochloride | Oral | Tablet | 017111 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Montelukast Sodium | Oral | Tablet | 020829 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Montelukast Sodium | Oral | Tablet, Chewable | 020830 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Montelukast Sodium | Oral | Granule | 021409 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Morphine Sulfate | Oral | Tablet | 022207 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Moxidectin | Oral | Tablet | 210867 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Moxifloxacin Hydrochloride | Oral | Tablet | 021085 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Mycophenolate Mofetil | Oral | Capsule | 050722 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Mycophenolate Mofetil | Oral | Tablet | 050723 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Mycophenolate Mofetil | Oral | Suspension | 050759 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Nabumetone | Oral | Tablet | 019583 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Nadolol | Oral | Tablet | 018063 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Naldemedine Tosylate | Oral | Tablet | 208854 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Naltrexone Hydrochloride | Oral | Tablet | 018932 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Naproxen | Oral | Tablet | 017581 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Naproxen | Oral | Suspension | 018965 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Naproxen Sodium | Oral | Tablet | 018164 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Naproxen Sodium | Oral | Tablet | 020204 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Naproxen Sodium | Oral | Capsule | 021920 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Naratriptan Hydrochloride | Oral | Tablet | 020763 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Nateglinide | Oral | Tablet | 021204 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Nebivolol Hydrochloride | Oral | Tablet | 021742 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Nebivolol Hydrochloride; Valsartan | Oral | Tablet | 206302 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Neratinib Maleate | Oral | Tablet | 208051 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Netupitant; Palonosetron Hydrochloride | Oral | Capsule | 205718 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Nevirapine | Oral | Tablet | 020636 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Nevirapine | Oral | Suspension | 020933 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Nicardipine Hydrochloride | Oral | Capsule | 019488 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Nimodipine | Oral | Capsule | 018869 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Nitisinone | Oral | Suspension | 206356 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Nitisinone | Oral | Tablet | 209449 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Nitrofurantoin | Oral | Suspension | 009175 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Nitrofurantoin, Macrocrystalline | Oral | Capsule | 016620 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Nitrofurantoin; Nitrofurantoin, Macrocrystalline | Oral | Capsule | 020064 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Norethindrone | Oral-28 | Tablet | 016954 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Norethindrone | Oral-28 | Tablet | 017060 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Norethindrone Acetate | Oral | Tablet | 018405 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Nortriptyline Hydrochloride | Oral | Capsule | 018013 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Obeticholic Acid | Oral | Tablet | 207999 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Olanzapine | Oral | Tablet | 020592 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Olanzapine | Oral | Tablet, Orally Disintegrating | 021086 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Olanzapine; Samidorphan L-Malate | Oral | Tablet | 213378 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Olmesartan Medoxomil | Oral | Tablet | 021286 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Omaveloxolone | Oral | Capsule | 216718 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Omega-3-Acid Ethyl Esters Type A | Oral | Capsule | 204977 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Complex | 10/2024 |
| Ondansetron | Oral | Tablet, Orally Disintegrating | 020781 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ondansetron Hydrochloride | Oral | Tablet | 020103 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Oseltamivir Phosphate | Oral | Capsule | 021087 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Oseltamivir Phosphate | Oral | For Suspension | 021246 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Osilodrostat Phosphate | Oral | Tablet | 212801 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Osimertinib Mesylate | Oral | Tablet | 208065 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ospemifene | Oral | Tablet | 203505 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Oteseconazole | Oral | Capsule | 215888 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Oxaprozin | Oral | Tablet | 018841 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Oxazepam | Oral | Capsule | 015539 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Oxcarbazepine | Oral | Tablet | 021014 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Oxcarbazepine | Oral | Suspension | 021285 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Oxybutynin Chloride | Oral | Tablet | 017577 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Oxycodone Hydrochloride | Oral | Tablet | 021011 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Oxycodone Hydrochloride | Oral | Capsule | 200534 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Oxymetholone | Oral | Tablet | 016848 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ozanimod Hydrochloride | Oral | Capsule | 209899 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Pacritinib Citrate | Oral | Capsule | 208712 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Palbociclib | Oral | Capsule | 207103 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Palonosetron Hydrochloride | Oral | Capsule | 022233 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Panobinostat Lactate | Oral | Capsule | 205353 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Paroxetine Hydrochloride | Oral | Tablet | 020031 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Paroxetine Mesylate | Oral | Tablet | 021299 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Paroxetine Mesylate | Oral | Capsule | 204516 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Pemigatinib | Oral | Tablet | 213736 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Penbutolol Sulfate | Oral | Tablet | 018976 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Penicillin V Potassium | Oral | Tablet | 065435 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Perampanel | Oral | Tablet | 202834 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Perampanel | Oral | Suspension | 208277 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Perindopril Erbumine | Oral | Tablet | 020184 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Perphenazine | Oral | Tablet | 010775 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Phenelzine Sulfate | Oral | Tablet | 011909 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Phentermine Hydrochloride | Oral | Tablet, Orally Disintegrating | 202088 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Pilocarpine Hydrochloride | Oral | Tablet | 020237 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Pimavanserin Tartrate | Oral | Tablet | 207318 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A; Add a BCS-based biowaiver option | Non-Complex | 10/2024 |
| Pimavanserin Tartrate | Oral | Capsule | 210793 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A; Add a BCS-based biowaiver option | Non-Complex | 10/2024 |
| Pimozide | Oral | Tablet | 017473 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Pindolol | Oral | Tablet | 018285 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Pioglitazone Hydrochloride | Oral | Tablet | 021073 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Pirfenidone | Oral | Capsule | 022535 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Pirfenidone | Oral | Tablet | 208780 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Piroxicam | Oral | Capsule | 018147 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Pitavastatin Calcium | Oral | Tablet | 022363 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Pitavastatin Magnesium | Oral | Tablet | 208379 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Pitavastatin Sodium | Oral | Tablet | 209875 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Pitolisant Hydrochloride | Oral | Tablet | 211150 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Pomalidomide | Oral | Capsule | 204026 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ponesimod | Oral | Tablet | 213498 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Pramipexole Dihydrochloride | Oral | Tablet | 020667 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Prasugrel Hydrochloride | Oral | Tablet | 022307 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Pravastatin Sodium | Oral | Tablet | 019898 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Praziquantel | Oral | Tablet | 018714 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Prazosin Hydrochloride | Oral | Capsule | 017442 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Prednisolone | Oral | Tablet | 080354 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Prednisolone Acetate | Oral | Suspension | 022067 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Prednisolone Sodium Phosphate | Oral | Tablet, Orally Disintegrating | 021959 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Pregabalin | Oral | Capsule | 021446 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Primaquine Phosphate | Oral | Tablet | 008316 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Primidone | Oral | Tablet | 009170 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 11/2024 |
| Prochlorperazine Maleate | Oral | Tablet | 010571 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Promethazine Hydrochloride | Oral | Tablet | 007935 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Propafenone Hydrochloride | Oral | Tablet | 019151 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Propranolol Hydrochloride | Oral | Tablet | 016418 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Propylthiouracil | Oral | Tablet | 006188 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Protriptyline Hydrochloride | Oral | Tablet | 016012 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Prucalopride Succinate | Oral | Tablet | 210166 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Pyrazinamide | Oral | Tablet | 080157 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Pyridostigmine Bromide | Oral | Tablet | 009829 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Pyrimethamine | Oral | Tablet | 008578 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Quetiapine Fumarate | Oral | Tablet | 020639 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Quinapril Hydrochloride | Oral | Tablet | 019885 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Raloxifene Hydrochloride | Oral | Tablet | 020815 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ramelteon | Oral | Tablet | 021782 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ramipril | Oral | Capsule | 019901 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ramipril | Oral | Tablet | 022021 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ranitidine Hydrochloride | Oral | Tablet | 018703 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ranitidine Hydrochloride | Oral | Capsule | 020095 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ranitidine Hydrochloride | Oral | Tablet, Effervescent | 020745 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ranitidine Hydrochloride | Oral | Tablet | 020520; 021698 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Rasagiline Mesylate | Oral | Tablet | 021641 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 11/2024 |
| Relugolix | Oral | Tablet | 214621 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Repaglinide | Oral | Tablet | 020741 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Reserpine | Oral | Tablet | 009838 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ribavirin | Oral | Capsule | 020903 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ribavirin | Oral | Tablet | 021511 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ribociclib Succinate | Oral | Tablet | 209092 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Rifapentine | Oral | Tablet | 021024 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Rilpivirine Hydrochloride | Oral | Tablet | 202022 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Rimegepant Sulfate | Oral | Tablet, Orally Disintegrating | 212728 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Riociguat | Oral | Tablet | 204819 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Risperidone | Oral | Tablet | 020272 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Risperidone | Oral | Tablet, Orally Disintegrating | 021444 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Rivastigmine Tartrate | Oral | Capsule | 020823 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Rizatriptan Benzoate | Oral | Tablet | 020864 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Rizatriptan Benzoate | Oral | Tablet, Orally Disintegrating | 020865 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Roflumilast | Oral | Tablet | 022522 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Rolapitant Hydrochloride | Oral | Tablet | 206500 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ropinirole Hydrochloride | Oral | Tablet | 020658 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Rosiglitazone Maleate | Oral | Tablet | 021071 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Rosuvastatin Calcium | Oral | Tablet | 021366 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Rufinamide | Oral | Tablet | 021911 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Rufinamide | Oral | Suspension | 201367 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ruxolitinib Phosphate | Oral | Tablet | 202192 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Sacubitril; Valsartan | Oral | Tablet | 207620 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Safinamide Mesylate | Oral | Tablet | 207145 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Sapropterin Dihydrochloride | Oral | Tablet | 022181 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Sarecycline Hydrochloride | Oral | Tablet | 209521 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Saxagliptin Hydrochloride | Oral | Tablet | 022350 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Selegiline Hydrochloride | Oral | Tablet, Orally Disintegrating | 020647 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Selegiline Hydrochloride | Oral | Capsule | 021479 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Selexipag | Oral | Tablet | 207947 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Selpercatinib | Oral | Capsule | 213246 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Sertraline Hydrochloride | Oral | Tablet | 019839 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Sertraline Hydrochloride | Oral | Capsule | 215133 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Sibutramine Hydrochloride | Oral | Capsule | 020632 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Sildenafil Citrate | Oral | For Suspension | 203109 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Sildenafil Citrate | Oral | Tablet | 020895; 021845 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Silodosin | Oral | Capsule | 022206 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Simvastatin | Oral | Tablet | 019766 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Simvastatin | Oral | Tablet, Orally Disintegrating | 021961 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Simvastatin; Sitagliptin Phosphate | Oral | Tablet | 202343 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Siponimod Fumaric Acid | Oral | Tablet | 209884 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Sitagliptin Phosphate | Oral | Tablet | 021995 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Sodium Phenylbutyrate | Oral | Tablet | 020572 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Sodium Phenylbutyrate | Oral | Powder | 020573 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Sodium Phenylbutyrate; Taurursodiol | Oral | For Suspension | 216660 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Sofosbuvir | Oral | Tablet | 204671 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Solifenacin Succinate | Oral | Tablet | 021518 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Solriamfetol Hydrochloride | Oral | Tablet | 211230 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Sotalol Hydrochloride | Oral | Tablet | 019865 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Sotalol Hydrochloride | Oral | Tablet | 021151 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Sotorasib | Oral | Tablet | 214665 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Sparsentan | Oral | Tablet | 216403 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Spironolactone | Oral | Tablet | 012151 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Spironolactone | Oral | Suspension | 209478 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Stavudine | Oral | Capsule | 020412 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Stiripentol | Oral | Capsule | 206709 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Stiripentol | Oral | For Suspension | 207223 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Succimer | Oral | Capsule | 019998 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Sulfadiazine | Oral | Tablet | 004122 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Sulfamethoxazole; Trimethoprim | Oral | Tablet | 017377 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Sulfamethoxazole; Trimethoprim | Oral | Suspension | 017560 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Sumatriptan Succinate | Oral | Tablet | 020132 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Tadalafil | Oral | Tablet | 021368; 022332 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Tafenoquine Succinate | Oral | Tablet | 210607 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Tafenoquine Succinate | Oral | Tablet | 210795 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Tamoxifen Citrate | Oral | Tablet | 017970 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Tapentadol Hydrochloride | Oral | Tablet | 022304 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Tasimelteon | Oral | Suspension | 214517 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Tecovirimat | Oral | Capsule | 208627 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Tedizolid Phosphate | Oral | Tablet | 205435 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Telbivudine | Oral | Tablet | 022011 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Telithromycin | Oral | Tablet | 021144 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Telotristat Etiprate | Oral | Tablet | 208794 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Temazepam | Oral | Capsule | 018163 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Tenofovir Alafenamide Fumarate | Oral | Tablet | 208464 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Tenofovir Disoproxil Fumarate | Oral | Tablet | 021356 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Tenofovir Disoproxil Fumarate | Oral | Powder | 022577 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Tepotinib Hydrochloride | Oral | Tablet | 214096 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Terazosin Hydrochloride | Oral | Capsule | 020347 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Terbinafine Hydrochloride | Oral | Tablet | 020539 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Terbinafine Hydrochloride | Oral | Granule | 022071 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Terbutaline Sulfate | Oral | Tablet | 017849 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Teriflunomide | Oral | Tablet | 202992 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Testosterone Undecanoate | Oral | Capsule | 213953 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Tetrabenazine | Oral | Tablet | 021894 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Tetracycline Hydrochloride | Oral | Capsule | 050278 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Thalidomide | Oral | Capsule | 20785 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 02/2025 |
| Thioridazine Hydrochloride | Oral | Tablet | 011808 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Thiothixene | Oral | Capsule | 016584 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Tiagabine Hydrochloride | Oral | Tablet | 020646 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ticagrelor | Oral | Tablet | 022433 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ticlopidine Hydrochloride | Oral | Tablet | 019979 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Timolol Maleate | Oral | Tablet | 018017 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Tivozanib Hydrochloride | Oral | Capsule | 212904 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Tizanidine Hydrochloride | Oral | Tablet | 020397 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Tizanidine Hydrochloride | Oral | Capsule | 21447 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 02/2025 |
| Tofacitinib Citrate | Oral | Tablet | 203214 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Tolcapone | Oral | Tablet | 020697 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Tolterodine Tartrate | Oral | Tablet | 020771 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Topiramate | Oral | Tablet | 020505 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Topiramate | Oral | Capsule | 020844 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Toremifene Citrate | Oral | Tablet | 020497 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Torsemide | Oral | Tablet | 020136 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Torsemide | Oral | Tablet | 213218 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Trandolapril | Oral | Tablet | 020528 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Tranylcypromine Sulfate | Oral | Tablet | 012342 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Trazodone Hydrochloride | Oral | Tablet | 018207 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Triamterene | Oral | Capsule | 013174 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Triazolam | Oral | Tablet | 017892 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Triclabendazole | Oral | Tablet | 208711 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Trimethoprim | Oral | Tablet | 018679 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Trimipramine Maleate | Oral | Capsule | 016792 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ubrogepant | Oral | Tablet | 211765 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ulipristal Acetate | Oral | Tablet | 022474 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Uridine Triacetate | Oral | Granule | 208159; 208169 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ursodiol | Oral | Capsule | 019594 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ursodiol | Oral | Tablet | 020675 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Valacyclovir Hydrochloride | Oral | Tablet | 020487 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Valbenazine Tosylate | Oral | Capsule | 209241 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Valganciclovir Hydrochloride | Oral | Tablet | 021304 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Valsartan | Oral | Tablet | 021283 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Vandetanib | Oral | Tablet | 022405 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Vardenafil Hydrochloride | Oral | Tablet, Orally Disintegrating | 021400 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Vardenafil Hydrochloride | Oral | Tablet | 200179 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Varenicline Tartrate | Oral | Tablet | 021928 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Verapamil Hydrochloride | Oral | Tablet | 018593; 018817 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 02/2025 |
| Vericiguat | Oral | Tablet | 214377 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Vibegron | Oral | Tablet | 213006 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Vilazodone Hydrochloride | Oral | Tablet | 022567 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Vismodegib | Oral | Capsule | 203388 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Vorapaxar Sulfate | Oral | Tablet | 204886 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Vortioxetine Hydrobromide | Oral | Tablet | 204447 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Voxelotor | Oral | Tablet | 213137 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Voxelotor | Oral | Tablet, For Suspension | 216157 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Zalcitabine | Oral | Tablet | 020199 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Zaleplon | Oral | Capsule | 020859 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Zidovudine | Oral | Capsule | 019655 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Zidovudine | Oral | Tablet | 020518 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Zileuton | Oral | Tablet | 020471 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ziprasidone Hydrochloride | Oral | Capsule | 020825 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Ziprasidone Hydrochloride | Oral | Suspension | 021483 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Zolmitriptan | Oral | Tablet | 020768 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Zolmitriptan | Oral | Tablet, Orally Disintegrating | 021231 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Zolpidem Tartrate | Oral | Tablet | 019908 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |
| Zonisamide | Oral | Capsule | 020789 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 10/2024 |