Drugs
Bioequivalence Recommendations for Specific Products
- Drug-Related Guidances Main Page
- Bioequivalence Recommendations for Specific Products (PDF - 81KB) (Issued June 2010)
- Dissolutions Methods Database
"Please submit comments for any of the guidances posted in the Bioequivalence Recommendations for Specific Products website to the Division of Dockets Management (DDM) under Docket FDA-2007-D-0369-0015. For electronic comments refer to the website http://www.regulations.gov OR you can mail your written comments to DDM (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Please contact the Regulations.gov HelpDesk at 1-877-378-5457 (toll free) for assistance regarding submissions."
Bioequivalence Recommendations for Specific Products Arranged by Active Ingredient
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Newly Added Recommendations - March/April 2013 ( 31 New; 13 Revision) updated 4/29/2013
| Active Ingredient (link to Specific Guidance) | Type | Route of Administration | Dosage Form | RLD Application Number (link to Orange Book) | Date Recommended |
|---|---|---|---|---|---|
|
| |||||
Albuterol Sulfate (PDF - 144KB) | Draft | Inhalation | Aerosol, Metered | 4/2013 | |
| Draft | Oral | Tablet, Extended Release | 50813 | 4/2013 | |
| Bupropion HCl (PDF - 34KB) | Draft | Oral | Tablet, Extended-Release | 22497 | 3/2013 |
| Draft | Oral | Capsule | 203195 | 4/2013 |
| Draft | Oral | Tablet | 4/2013 | |
| Draft | Oral | Tablet, Extended Release | 4/2013 | |
| Dutasteride;Tamsulosin HCl (PDF -62KB) | Draft | Oral | Capsule | 022460 | 4/2013 |
| Estramustine Phosphate Sodium (PDF - 24KB) | Draft | Oral | Capsule | 018045 | 4/2013 |
| Ethinyl Estradiol; Etonogestrel (PDF - 22KB) | Draft | Vaginal | Ring | 21187 | 4/2013 |
| Draft | Oral | Tablet | 4/2013 | |
| Draft | Oral | Tablet | 22345 | 4/2013 |
| Flutamide (PDF - 23KB) | Draft | Oral | Capsule | 075780 | 4/2013 |
| Hydrocortisone (PDF - 22KB) | Draft | Oral | Tablet | 08697 | 4/2013 |
| Icosapent Ethyl (PDF - 83KB) | Draft | Oral | Capsule, Gel | 202057 | 4/2013 |
| Ketorolac Tromethamine (PDF - 25KB) | Draft | Nasal | Spray, Metered | 22382 | 4/2013 |
| Loratadine (PDF - 22KB) | Draft | Oral | Capsule | 021952 | 4/2013 |
| Metronidazole (PDF - 112KB) | Draft | Vaginal | Gel | 21806 | 4/2013 |
| Miconazole (PDF - 63KB) | Draft | Buccal | Tablet | 22404 | 4/2013 |
| Minocycline HCl (PDF - 24KB) | Draft | Oral | Capsule, Extended Release | 201922 | 4/2013 |
| Mitotane (PDF -21KB) | Draft | Oral | Tablet | 016885 | 4/2013 |
| Nevirapine (PDF - 24KB) | Draft | Oral | Tablet, Extended Release | 201152 | 4/2013 |
| Rimexolone (PDF - 21KB) | Draft | Ophthalmic | Drops, Suspension | 020474 | 4/2013 |
| Rizatriptan Benzoate (PDF - 21KB) | Draft | Oral | Tablet, Orally Disintegrating | 20865 | 4/2013 |
| Silodosin (PDF - 24KB) | Draft | Oral | Capsule | 22206 | 4/2013 |
| Testosterone (PDF -27KB)1% | Draft | Transdermal | Gel, Metered | 21015 | 4/2013 |
| Testosterone (PDF - 27KB) 1.62% | Draft | Transdermal | Gel, Metered | 22309 | 4/2013 |
| Testosterone (PDF - 26KB) 10 mg/0.5 gm gel | Draft | Transdermal | Gel, Metered | 21463 | 4/2013 |
| Testosterone (PDF - 27KB)1% | Draft | Transdermal | Gel | 21015 | 4/2013 |
| Testosterone (PDF - 27KB) 1% | Draft | Transdermal | Gel | 21454 | 4/2013 |
| Testosterone (PDF - 27KB) 1.62% | Draft | Transdermal | Gel | 22309 | 4/2013 |
| Testosterone (PDF - 21KB) | Draft | Transdermal | Solution, Metered | 22504 | 4/2013 |
| Zolpidem Tartrate (PDF - 25KB) | Draft | Oral | Spray | 022196 | 4/2013 |
| Revisions | |||||
|---|---|---|---|---|---|
| Active Ingredient (link to Specific Guidance) | Type | Route of Administration | Dosage Form | RLD Application Number (link to Orange Book) | Date Recommended |
| Bupropion HBr (PDF - 21KB) Revised | Draft | Oral | Tablet, Extended Release | 22108 | 3/2013 |
| Bupropion HCl (PDF - 34KB)Revised | Draft | Oral | Tablet | 18644 | 3/2013 |
| Bupropion HCl (PDF - 22KB) Revised | Draft | Oral | Tablet, Extended Release | 21515 | 3/2013 |
| Bupropion HCl (PDF - 34KB)Revised | Draft | Oral | Tablet, Extended-Release | 3/2013 | |
| Cefixime (PDF - 18KB)Revised | Draft | Oral | Suspension | 4/2013 | |
| Darunavir Ethanolate (PDF-49KB) Revised | Draft | Oral | Tablet | 21976 | 4/2013 |
| Dextromethorphan Hydrobromide; Quinidine Sulfate (PDF - 39KB)Revised | Draft | Oral | Capsule | 21879 | 4/2013 |
| Imatinib Mesylate (PDF - 31KB)Revised | Final | Oral | Tablet | 21588 | 4/2013 |
| Loteprednol Etabonate (PDF - 58KB)Revised | Draft | Ophthalmic | Drops, suspension | 4/2013 | |
| Mesalamine (PDF - 35KB)Revised | Draft | Rectal | Suppository | 21252 | 3/2013 |
