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: January 13, 2026

Active Ingredient(s)	Route of Administration	Dosage Form	RLD or RS Application Number	Product Complexity	Planned Publication	Updates
Aceclidine Hydrochloride	Ophthalmic	Solution/Drops	218585	Non-Complex	02/2026	No change
Acetaminophen	Intravenous	Solution	206968	Non-Complex	02/2026	No change
Acoltremon	Ophthalmic	Solution/Drops	217370	Non-Complex	02/2026	No change
Alpelisib	Oral	Tablet	215039	Non-Complex	02/2026	No change
Alpelisib	Oral	Granules	218466	Non-Complex	02/2026	No change
Amikacin Sulfate	Inhalation	Suspension, Liposomal	207356	Complex	Beyond 12 months	No change
Amlodipine Besylate; Indapamide; Telmisartan	Oral	Tablet	219423	Non-Complex	05/2026	No change
Apixaban	Oral	For Suspension	220073	Non-Complex	02/2026	No change
Apremilast	Oral	Tablet, Extended Release	210745	Non-Complex	05/2026	No change
Aripiprazole	Oral	Tablet	207202	Complex	Within the next 12 months	No change
Articaine Hydrochloride	Ophthalmic	Solution/Drops	218643	Non-Complex	05/2026	Newly added
Atrasentan Hydrochloride	Oral	Tablet	219208	Non-Complex	05/2026	No change
Avacincaptad Pegol Sodium	Intravitreal	Solution	217225	Complex	02/2026	No change
Avutometinib Potassium; Defactinib Hydrochloride	Oral	Capsule, Tablet	219616	Non-Complex	05/2026	No change
Bisoprolol Fumarate	Oral	Tablet	019982	Non-Complex	02/2026	No change
Brensocatib	Oral	Tablet	217673	Non-Complex	08/2026	Newly added
Buprenorphine	Subcutaneous	Solution, Extended Release	210136	Complex	02/2026	No change
Carboplatin	Intravenous	Solution	219921	Non-Complex	05/2026	Newly added
Cephalexin	Oral	Tablet	063024	Non-Complex	02/2026	Planned publication date assigned
Clobetasol Propionate	Topical	Cream	209483	Complex	Beyond 12 months	No change
Copper	Intrauterine	System	218201	Complex	05/2026	No change
Cysteamine Bitartrate	Oral	Capsule	020392	Non-Complex	08/2026	Newly added
Dabrafenib Mesylate	Oral	Tablet, For Suspension	217514	Non-Complex	02/2026	No change
Desmopressin Acetate	Nasal	Spray, Metered	201656	Complex	05/2026	No change
Dexamethasone	Ophthalmic	Insert	208742	Complex	02/2026	No change
Dexamethasone	Oral	Tablet	211379	Non-Complex	05/2026	No change
Diazoxide Choline	Oral	Tablet, Extended Release	216665	Non-Complex	02/2026	No change
Diclofenac Sodium	Topical	Gel	022122	Complex	02/2026	Newly added
Dihydroergotamine Mesylate	Nasal	Powder	217901	Complex	08/2026	Newly added
Donidalorsen Sodium	Subcutaneous	Solution	219407	Complex	08/2026	Newly added
Dordaviprone	Oral	Capsule	219876	Non-Complex	05/2026	No change
Drospirenone	Oral	Tablet, Chewable	216285	Non-Complex	05/2026	No change
Entrectinib	Oral	Pellets	218550	Non-Complex	02/2026	No change
Ezetimibe; Rosuvastatin Calcium	Oral	Tablet	213072	Non-Complex	Within the next 12 months	No change
Fitusiran Sodium	Subcutaneous	Solution	219019	Complex	05/2026	No change
Fluconazole	Oral	For Suspension	020090	Non-Complex	Beyond 12 months	Planned publication date change to a later date
Folic Acid	Oral	Solution	FDA-2024-P-0422	Non-Complex	05/2026	Newly added
Foscarbidopa; Foslevodopa	Subcutaneous	Solution	216962	Complex	02/2026	No change
Glecaprevir; Pibrentasvir	Oral	Pellets	215110	Non-Complex	02/2026	No change
Iloprost	Inhalation	Solution	021779	Non-Complex	05/2026	No change
Imatinib Mesylate	Oral	Solution	219097	Non-Complex	02/2026	No change
Imetelstat Sodium	Intravenous	Powder	217779	Complex	05/2026	No change
Imlunestrant Tosylate	Oral	Tablet	218881	Non-Complex	11/2026	Newly added
Lamotrigine	Oral	Suspension	218879	Non-Complex	11/2026	Newly added
Landiolol Hydrochloride	Intravenous	Powder	217202	Non-Complex	02/2026	No change
Lanreotide Acetate	Subcutaneous	Solution	215395	Complex	Within the next 12 months	No change
Lenacapavir Sodium	Oral	Tablet	220020	Non-Complex	05/2026	No change
Letermovir	Oral	Pellets	219104	Non-Complex	02/2026	No change
Levamlodipine Maleate	Oral	Tablet	212895	Non-Complex	Within the next 12 months	No change
Lidocaine; Tetracaine	Topical	Patch	021623	Complex	Beyond 12 months	No change
Lisdexamfetamine Dimesylate	Oral	Solution	219847	Non-Complex	05/2026	No change
Meloxicam; Rizatriptan Benzoate	Oral	Tablet	215431	Non-Complex	02/2026	No change
Metoprolol Tartrate	Oral	Solution	219373	Non-Complex	05/2026	Newly added
Metprolol Tartrate	Oral	Tablet	218698	Non-Complex	05/2026	Newly added
Mirdametinib	Oral	Tablet, For Suspension	219379	Non-Complex	05/2026	No change
Mirdametinib	Oral	Capsule	219389	Non-Complex	05/2026	No change
Mometasone Furoate	Implantation	Implant	209310	Complex	02/2026	No change
Nicotine	Oral	Inhalant	020714	Complex	08/2026	No change
Nimodipine	Oral	Solution	203340	Non-Complex	08/2026	Planned publication date change to a later date
Olezarsen Sodium	Subcutaneous	Solution	218614	Complex	08/2026	No change
Paliperidone Palmitate	Intramuscular	Suspension, Extended Release	216352	Complex	02/2026	No change
Palopegteriparatide	Subcutaneous	Solution	216490	Complex	05/2026	Planned publication date change to a later date
Paltusotine Hydrochloride	Oral	Tablet	219070	Non-Complex	11/2026	Newly added
Patiromer Sorbitex Calcium	Oral	Powder	205739	Complex	Within the next 12 months	No change
Pentamidine Isethionate	Inhalation	For Solution	019887	Non-Complex	05/2026	No change
Phenylephrine Hydrochloride; Tropicamide	Ophthalmic	Spray, Metered	215352	Complex	02/2026	Newly added
Remibrutinib	Oral	Tablet	218436	Non-Complex	11/2026	Newly added
Ribavirin	Inhalation	For Solution	018859	Non-Complex	02/2026	No change
Rilpivirine Hydrochloride	Oral	Tablet, For Suspension	219016	Non-Complex	02/2026	No change
Riluzole	Oral	Film	212640	Non-Complex	08/2026	Planned publication date change to a later date
Rilzabrutinib	Oral	Tablet	219685	Non-Complex	08/2026	Newly added
Rizatriptan	Oral	Film	205394	Non-Complex	08/2026	Planned publication date change to a later date
Sebetralstat	Oral	Tablet	219301	Non-Complex	08/2026	Newly added
Semaglutide	Oral	Tablet	218316	Complex	02/2026	Newly added
Sunvozertinib	Oral	Tablet	219839	Non-Complex	08/2026	Newly added
Selumetinib Sulfate	Oral	Granule	219943	Non-Complex	05/2026	Newly added
Sepiapterin	Oral	Powder	219666	Non-Complex	11/2026	Newly added
Sofosbuvir; Velpatasvir	Oral	Pellets	214187	Non-Complex	02/2026	No change
Tadalafil	Oral	Tablet, Chewable	218527	Non-Complex	Beyond 12 months	Planned publication date change to a later date
Tadalafil	Oral	Suspension	214522	Non-Complex	02/2026	No change
Taletrectinib Adipate	Oral	Capsule	219713	Non-Complex	08/2026	No change
Teriparatide	Subcutaneous	Solution	218771	Complex	12/2025	Posted on 12/04/25 with Revised PSG for NDA 021318
Testosterone Cypionate	Injection	Injectable	085635	Non-Complex	02/2026	No change
Testosterone Cypionate	Intramuscular	Solution	216318	Non-Complex	02/2026	No change
Tolmetin Sodium	Oral	Tablet	017628	Non-Complex	02/2026	No change
Tolmetin Sodium	Oral	Capsule	018084	Non-Complex	02/2026	No change
Vimseltinib	Oral	Capsule	219304	Non-Complex	08/2026	Planned publication date change to a later date
Warfarin Sodium	Oral	Solution	FDA-2024-P-5808	Non-Complex	05/2026	Newly added
Zanubrutinib	Oral	Tablet	218785	Non-Complex	05/2026	No change
Zolpidem Tartrate	Oral	Capsule	215721	Non-Complex	08/2026	Planned publication date change to a later date
Zongertinib	Oral	Tablet	219042	Non-Complex	11/2026	Newly added

Planned Revised PSGs for Complex and Non-Complex
Generic Drug Products
Updated: December 8, 2025

Active Ingredient(s)	Route Of Administration	Dosage Form	RLD or RS Application Number	Planned Revision Category with Description	Product Complexity	Planned Publication	Updates
Acetaminophen; Ibuprofen	Oral	Tablet	211733	Minor Revison: Add an in vivo BE option	Non-Complex	02/2026	No change
Albuterol Sulfate	Inhalation	Aerosol, Metered	020503; 020983; 021457	Minor Revision: Clarify in vitro study design	Complex	02/2026	No change
Albuterol Sulfate; Budesonide	Inhalation	Aerosol, Metered	214070	Minor Revision: Clarify in vitro study design	Complex	02/2026	No change
Alpelisib	Oral	Tablet	212526	Minor Revison: Remove recommendations on fasting BE study to align with ICH M13A	Non-Complex	02/2026	No change
Amoxicillin; Omeprazole Magnesium; Rifabutin	Oral	Capsule, Delayed Release	213004	Minor Revison: Remove recommendations on in vitro test Editorial Revision: Update the langauge	Non-Complex	02/2026	No change
Amphetamine	Oral	Suspension	204325	Minor Revision: Change in study design for in vivo BE study(ies)	Non-Complex	08/2026	Newly added
Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate	Oral	Suspension	208147	Minor Revision: Change in study design for in vivo BE study(ies)	Non-Complex	08/2026	Newly added
Apixaban	Oral	Tablet	202155	Minor Revison: Add information on newly approved (lower or middle) strengths of the RLD	Non-Complex	02/2026	No change
Aripiprazole	Intramuscular	For Suspension, Extended release	202971	Minor Revision: Add an in vitro BE option	Complex	05/2026	No change
Asenapine	Transdermal	System	212268	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances Minor Revision: Clarify in vivo study design; Add an in vitro BE option as an alternative BE approach	Complex	02/2026	No change
Baclofen	Oral	Suspension	215602	In Vitro Major Revision: Add an in vitro BE study(ies)	Non-Complex	02/2026	No change
Baloxavir Marboxil	Oral	For Suspension	214410	In Vivo Major Revision: Change in study design for in vivo BE study(ies) (to add a new higher strength)	Non-Complex	02/2026	No change
Barium Sulfate	Oral	Suspension	208036	Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD	Complex	02/2026	No change
Barium Sulfate	Oral	Suspension	208143	Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD	Complex	02/2026	No change
Beclomethasone Dipropionate	Inhalation	Aerosol, Metered	207921	Minor Revision: Clarify in vitro study design	Complex	02/2026	No change
Beclomethasone Dipropionate	Inhalation	Aerosol, Metered	020911	Minor Revision: Clarify in vitro study design	Complex	02/2026	No change
Budesonide; Formoterol Fumarate Dihydrate	Inhalation	Aerosol, Metered	216579	Minor Revision: Clarify in vitro study design	Complex	02/2026	No change
Budesonide; Formoterol Fumarate Dihydrate	Inhalation	Aerosol, Metered	021929	Minor Revision: Clarify in vitro study design	Complex	02/2026	No change
Budesonide; Formoterol Fumarate; Glycopyrrolate	Inhalation	Aerosol, Metered	212122	Minor Revision: Clarify in vitro study design	Complex	02/2026	No change
Buprenorphine	Transdermal	Film, Extended Release	021306	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Buprenorphine	Subcutaneous	Solution, Extended Release	209819	Minor Revision: Add an in vitro BE option	Complex	02/2026	No change
Buspirone Hydrochloride	Oral	Tablet	018731	Minor Revision: Provide more details on in vitro testing	Non-Complex	02/2026	No change
Cabotegravir	Intramuscular	Suspension, Extended Release	215499	Minor Revision: Clarify in vivo study design	Complex	05/2026	No change
Cabotegravir; Rilpivirine	Intramuscular	Suspension, Extended Release	212888	Minor Revision: Clarify in vivo study design	Complex	05/2026	No change
Capsaicin	Topical	Patch	022395	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Cephalexin	Oral	For Suspension	050406	Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD	Non-Complex	05/2026	Newly added
Chlorthalidone	Oral	Tablet	218647	Minor Revision: Update the language to include all relevant RLD/RS within a single PSG	Non-Complex	02/2026	No change
Ciclesonide	Inhalation	Aerosol, Metered	021658	Minor Revision: Clarify in vitro study design	Complex	02/2026	No change
Clindamycin Phosphate	Vaginal	Suppository	050767	Minor Revision: Add an in vitro BE option; Add recommendations for device comparisons Editorial Revision: Update the language	Complex	05/2026	Planned publication date change to a later date
Clonidine	Transdermal	System	018891	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Clozapine	Oral	Suspension	203479	Minor Revision: Remove recommendations on REMS/ETASU	Non-Complex	02/2026	No change
Clozapine	Oral	Tablet	019758	Minor Revision: Remove recommendations on REMS/ETASU	Non-Complex	02/2026	No change
Clozapine	Oral	Tablet, Orally Disintegrating	021590	Minor Revision: Remove recommendations on REMS/ETASU	Non-Complex	02/2026	No change
Cobicistat; Darunavir	Oral	Tablet	205395	Minor Revison: Add information on newly approved (lower or middle) strengths of the RLD	Non-Complex	02/2026	No change
Cysteamine Bitartrate	Oral	Granule, Delayed Release	203389	Minor Revision: Remove recommendations on in vitro test	Non-Complex	02/2026	Newly added
Cysteamine Bitartrate	Oral	Granule, Delayed Release	213491	Minor Revision: Remove recommendations on in vitro test	Non-Complex	02/2026	No change
Dasitinib	Oral	Tablet	021986	Editorial Revison: Update the language	Non-Complex	02/2026	No change
Dextroamphetamine	Transdermal	System	215401	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Diclofenac Epolamine	Topical	System	021234	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Disclofenac Sodium	Topical	Gel	022122	Minor Revision: Remove recommendations on device information	Complex	02/2026	Newly added
Donepezil Hydrochloride	Transdermal	System	212304	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Duloxetine Hydrochloride	Oral	Capsule, Delayed Release Pellet	021427	Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD	Non-Complex	02/2026	Newly added
Duloxetine Hydrochloride	Oral	Capsule, Delayed Release Pellet	212516	Minor Revision: Remove recommendations on in vitro test	Non-Complex	02/2026	Newly added
Epinephrine	Inhalation	Aerosol, Metered	205920	Minor Revision: Clarify in vitro study design	Complex	02/2026	No change
Esomeprazole Magnesium	Oral	Powder For Suspension, Delayed Release	021957; 022101	In Vitro Major Revision: Add an in vitro study(ies)  Minor Revision: Clarify in vitro study design	Non-Complex	05/2026	Newly added
Estradiol	Transdermal	Film, Extended Release	203752	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Estradiol	Transdermal	System; Film, Extended Release	21674; 020375	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Estradiol	Transdermal	System	020538	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Estradiol	Transdermal	System	019081	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Estradiol; Levonorgestrel	Transdermal	Film, Extended Release	021258	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Estradiol; Norethindrone Acetate	Transdermal	Film, Extended Release	020870	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Ethinyl Estradiol; Levonorgestrel	Transdermal	System	204017	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Ethinyl Estradiol; Norelgestromin	Transdermal	Film, Extended Release	021180	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Fentanyl	Transdermal	Film, Extended Release	019813	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances Minor Revision:  Add information on newly approved (lower or middle) strengths of the RLD; Revise recommendations related to irritation/sensitization study	Complex	02/2026	No change
Ferric Carboxymaltose	Intravenous	Solution	203565	Minor Revision: Clarify in vivo study design Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	08/2026	Newly added
Ferric Derisomaltose	Intravenous	Solution	208171	Minor Revision: Add in vivo BE option  Editorial: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidance	Complex	02/2026	No change
Ferumoxytol	Intravenous	Solution	022180	Minor Revision: Clarify in vivo study design Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	08/2026	Newly added
Flunisolide	Inhalation	Aerosol, Metered	021247	Minor Revision: Clarify in vitro study design	Complex	02/2026	No change
Fluorouracil	Topical	Cream	020985	Minor Revision: Add an in vitro BE option	Complex	Beyond 12 months	No change
Fluticasone Propionate	Inhalation	Aerosol, Metered	021433	Minor Revision: Clarify in vitro study design	Complex	02/2026	No change
Fluticasone Propionate; Salmeterol Xinafoate	Inhalation	Aerosol, Metered	021254	Minor Revision: Clarify in vitro study design	Complex	02/2026	No change
Formoterol Fumarate	Inhalation	Powder	020831	Editorial Revision: Correct typos	Complex	02/2026	No change
Formoterol Fumarate; Mometasone Furoate	Inhalation	Aerosol, Metered	022518	Minor Revision: Clarify in vitro study design	Complex	02/2026	No change
Glycopyrrolate; Formoterol Fumarate	Inhalation	Aerosol, Metered	208294	Minor Revision: Clarify in vitro study design	Complex	02/2026	No change
Granisetron	Transdermal	Film, Extended Release	022198	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Imatinib Mesylate	Oral	Tablet	021588	Minor Revison: Add an in vivo BE option	Non-Complex	02/2026	No change
Ipratropium Bromide	Inhalation	Aerosol, Metered	021527	Minor Revision: Clarify in vitro study design	Complex	02/2026	No change
Ketoconazole	Topical	Shampoo	020310	Minor Revision: Add an in vitro BE option Editorial Revision: Update the language	Complex	02/2026	No change
Ketoconazole	Topical	Shampoo	019927	Minor Revision: Add an in vitro BE option Editorial Revision: Update the language	Complex	02/2026	No change
Lanreotide Acetate	Subcutaneous	Solution	022074	Minor Revision: Add recommendations for device comparisons Editorial Revision: Update the language	Complex	Within the next 12 months	No change
Leuprolide Acetate	Subcutaneous	Powder	021343	Minor Revision: Add an in vitro study(ies) Editorial Revision: Update the language	Complex	05/2026	Newly added
Leuprolide Acetate	Subcutaneous	Powder	021379; 021488	Minor Revision: Add an in vitro study(ies) Editorial Revision: Update the language	Complex	05/2026	Newly added
Leuprolide Acetate	Subcutaneous	Powder	021731; 213150	Minor Revision: Add an in vitro study(ies) Editorial Revision: Update the language	Complex	05/2026	Newly added
Levalbuterol Tartrate	Inhalation	Aerosol, Metered	021730	Minor Revision: Clarify in vitro study design	Complex	02/2026	No change
Lidocaine	Topical	Patch	207962	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Lidocaine	Topical	Patch	020612	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Lorazepam	Oral	Capsule, Extended Release	214826	Minor Revison: Add information on newly approved (lower or middle) strengths of the RLD	Non-Complex	02/2026	No change
Lorlatinib	Oral	Tablet	210868	Minor Revision: Change in study design for in vivo BE study(ies)	Non-Complex	02/2026	Newly added
Loxapine	Inhalation	Powder	022549	Editorial Revision: Correct typos	Complex	02/2026	No change
Lutetium Lu 177 Dotatate	Intravenous	Solution	208700	Editorial Revision: Update the language to match Orange Book	Complex	Within the next 12 months	Planned publication date change to a later date
Menthol; Methyl Salicylate	Topical	Patch	022029	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Metformin Hydrochloride	Oral	Tablet, Chewable	020357 (FDA-2011-P-0558)	Minor Revision: Clarify in vivo study design	Non-Complex	02/2026	Newly added
Methylphenidate	Transdermal	Film, Extended Release	021514	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Metoprolol Succinate	Oral	Tablet, Extended Release	019962	Minor Revision: Add information on newly added (lower or middle) strengths based on approved suitability petition FDA-2012-P-0698-0003	Non-Complex	05/2026	Newly added
Mometasone Furoate	Inhalation	Aerosol, Metered	205641	Minor Revision: Clarify in vitro study design	Complex	02/2026	No change
Nicotine	Transdermal	Film, Extended Release	020076; 020165	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Nitroglycerin	Transdermal	Film, Extended Release	020145	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Nitroglycerin	Transdermal	Film, Extended Release	020144	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Octreotide Acetate	Subcutaneous	Solution	213224	Minor Revision: Add recommendation for device comparisons	Complex	02/2026	No change
Osilodrostat Phosphate	Oral	Tablet	212801	Minor Revison: Add an in vitro BE option	Non-Complex	05/2026	No change
Oxybutynin	Transdermal	Film, Extended Release	202211	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Oxybutynin	Transdermal	Film, Extended Release	021351	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Paliperidone Palmitate	Intramuscular	Suspension, Extended Release	022264	Minor Revision: Add an in vitro BE option	Complex	02/2026	No change
Pazopanib Hydrochloride	Oral	Tablet	022465	Minor Revision:  Change in study design for in vivo BE study(ies)	Non-Complex	08/2026	Newly added
Perfluorohexyloctane	Ophthalmic	Solution	216675	Minor Revision: Clarify in vitro study design	Non-Complex	02/2026	No change
Rivastigmine	Transdermal	Film, Extended Release	022083	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Rotigotine	Transdermal	Film, Extended Release	021829	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Sacubitril; Valsartan	Oral	Tablet	207620	In Vivo Major Revision: Add a fed BE study to align with ICH M13A	Non-Complex	02/2026	Newly added
Scopolamine	Transdermal	System	017874	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Selegiline	Transdermal	Film, Extended Release	021336	Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Selinexor	Oral	Tablet	212306	Minor Reision: Add information on newly approved (lower or middle) strengths of the RLD	Non-Complex	02/2026	No change
Semaglutide	Subcutaneous	Solution	209637	Minor Revision: Provide more details on in vitro testing	Complex	Within the next 12 months	No change
Tacrolimus	Oral	Tablet, Extended Release	206406	Minor Revision: Provide more details on product characterization	Non-Complex	05/2026	Newly added
Tacrolimus	Oral	Capsule, Extended Release	204096	Minor Revision: Provide more details on product characterization	Non-Complex	05/2026	Newly added
Tacrolimus	Oral	Capsule	050708	Minor Revision: Provide more details on product characterization	Non-Complex	05/2026	Newly added
Tacrolimus	Oral	For Suspension	210115	Minor Revision: Provide more details on product characterization	Non-Complex	05/2026	Newly added
Testosterone	Transdermal	Film, Extended Release	020489	Minor Revision:  Add information on newly approved (lower or middle) strengths of the RLD; Revise recommendations related to irritation/sensitization study Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances	Complex	02/2026	No change
Testosterone Undecanoate	Oral	Capsule	206089	Minor Revison: Change in study design for in vivo BE study	Non-Complex	02/2026	Newly added
Testosterone Undecanoate	Oral	Capsule	213953	In Vivo Major Revision: Add a fasting BE study to align with ICH M13A Minor Revison: Change in study design for in vivo BE study	Non-Complex	02/2026	Newly added
Tiopronin	Oral	Tablet, Delayed Release	211843	Minor Revision: Remove recommendations on in vitro test	Non-Complex	02/2026	No change
Tiotropium Bromide	Inhalation	Powder	021395	Minor Revision: Change in study design for in vivo BE study(ies)	Complex	05/2026	Newly added
Tizanidine Hydrochloride	Oral	Capsule	021447	Minor Revision: Remove recommendations on fed BE study to align with ICH M13A  Editorial Revision: Update the language	Non-Complex	02/2026	No change
Tofacitinib Citrate	Oral	Tablet	203214	Minor Revision: Add an in vitro BE option Editorial Revision: Update the language	Non-Complex	05/2026	Newly added
Venlafaxine Besylate	Oral	Tablet, Extended Release	215429	Minor Revision: Clarify in vivo study design Editorial Revision: Update the language	Non-Complex	02/2026	No change
Venlafaxine Hydrochloride	Oral	Tablet	020151	Minor Revision: Clarify in vivo study design Editorial Revision: Update the language	Non-Complex	02/2026	No change
Warfarin Sodium	Oral	Tablet	009218	Minor Revision: Clarify in vivo study design	Non-Complex	05/2026	Newly added