Drugs
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Bioequivalence Recommendations for Specific Products
- 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 - September 2012 ( 41 New; 18 Revision) updated 9/19/2012
| Active Ingredient (link to Specific Guidance) |
Type | Route of Administration | Dosage Form | RLD Application Number (link to Orange Book) |
Date Recommended |
|---|---|---|---|---|---|
|
|
|||||
| Draft | Oral | Capsule | 061926 | 9/2012 | |
|
|
Draft | Oral | Suspension | 50575 | 9/2012 |
| Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate (PDF - 78KB) | Draft | Oral | Capsule, Extended Release | 21303 | 9/2012 |
| Budesonide (PDF - 270KB) | Draft | Inhalation | Suspension | 20929 | 9/2012 |
|
|
Draft | Oral | Tablet, Extended Release |
|
9/2012 |
| Calcitonin-Salmon (PDF - 21KB) | Draft | Nasal | Spray, Metered | 20313 | 9/2012 |
| Carbidopa; Levodopa (PDF - 19KB) | Draft | Oral | Tablet, Extended Release | 19856 | 9/2012 |
| Carglumic Acid (PDF - 17KB) | Draft | Oral | Tablet | 22562 | 9/2012 |
| Ciclesonide (PDF - 25KB) | Draft | Nasal | Aerosol, Metered | 202129 | 9/2012 |
| Ciprofloxacin; Dexamethasone (PDF - 149KB | Draft | Otic | Suspension/Drops | 21573 | 9/2012 |
| Cyclophosphamide (PDF -KB) | Draft | Oral | Tablet | 040032 | 9/2012 |
| Dalteparin Sodium (PDF - 26KB) | Draft | Subcutaneous | Injection | 20287 | 9/2012 |
| Draft | Oral | Capsule | 018045 | 9/2012 | |
| Fentanyl Citrate (PDF - 19KB) | Draft | Sublingual | Tablet | 22510 | 9/2012 |
| Ketoconazole (PDF - 84KB) | Draft | Topical, suspension | Shampoo | 20310 | 9/2012 |
| Linagliptin (PDF - 17KB) | Draft | Oral | Tablet | 201280 | 9/2012 |
| Mesalamine (PDF - 66KB) | Draft | Oral | Capsule, Extended Release | 20049 | 9/2012 |
| Mesalamine (PDF - 65KB) | Draft | Oral | Capsule, Extended Release | 22301 | 9/2012 |
| Mesalamine (PDF - 67KB) | Draft | Oral | Tablet, Delayed Release | 19651 | 9/2012 |
| Mesalamine (PDF - 67KB) | Draft | Oral | Tablet, Delayed Release | 21830 | 9/2012 |
| Mesalamine (PDF - 66KB) | Draft | Oral | Tablet, Delayed Release | 22000 | 9/2012 |
| Methylphenidate HCl (PDF - 81KB) | Draft | Oral | Capsule, Extended Release | 21259 | 9/2012 |
| Draft | Oral | Tablet, Extended Release | 21121 | 9/2012 | |
| Nifedipine (PDF - 19KB) | Draft | Oral | Tablet, Extended Release | 20198 | 9/2012 |
| Omega-3-Acid Ethyl Esters (PDF - 100KB) | Draft | Oral | Capsule | 21654 | 9/2012 |
| Omeprazole (PDF - 17KB) | Draft | Oral | Tablet, Delayed Release | 022032 | 9/2012 |
| Paclitaxel (PDF - 68KB) | Draft | Injection | Suspension | 021660 | 9/2012 |
| Pazopanib HCl (PDF - 30KB) | Draft | Oral | Tablet | 022465 | 9/2012 |
| Pentosan Polysulfate Sodium (PDF - 90KB) | Draft | Oral | Capsule | 20193 | 9/2012 |
| Progesterone (PDF - 23KB) | Draft | Vaginal | Insert | 22057 | 9/2012 |
|
|
Draft | Oral | Tablet | 202022 | 9/2012 |
|
|
Draft | Oral | Tablet | 22522 | 9/2012 |
|
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Draft | Oral | Tablet | 22350 | 9/2012 |
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Draft | Oral | Tablet | 201917 | 9/2012 |
|
|
Draft | Oral | Powder | 022577 | 9/2012 |
| Thalidomide (PDF -20KB) | Draft | Oral | Capsule | 9/2012 | |
| Thioguanine (PDF - 18KB) | Draft | Oral | Tablet | 012429 | 9/2012 |
|
|
Draft | Topical | Cream | 19963 | 9/2012 |
| Tretinoin (PDF -132KB) (NDA 021108) | Draft | Topical | Cream | 21108 | 9/2012 |
| Tretinoin (PDF -133KB) (NDA 020475) | Draft | Topical | Gel (0.1%) | 20475 | 9/2012 |
| Tretinoin (PDF -133KB) (NDA 020475) | Draft | Topical | Gel (0.04%) | 20475 | 9/2012 |
| Revisions | |||||
|---|---|---|---|---|---|
| Active Ingredient (link to Specific Guidance) |
Type | Route of Administration | Dosage Form | RLD Application Number (link to Orange Book) |
Date Recommended |
| Azacitidine (PDF - 16 KB) Revised |
Draft | Oral | Injection | 50794 | 9/2012 |
| Azelaic Acid (PDF - 181KB)Revised | Draft | Topical | Gel | 21470 | 9/2012 |
| Capecitabine (PDF - 46KB) Revised | Draft | Oral | Tablet | 20896 | 9/2012 |
| Estrogens, Esterified (PDF - 19KB)Revised | Draft | Oral | Tablet | 84948 84949 84950 84951 |
9/2012 |
| Etravirine (PDF - 34KB) Revised | Draft | Oral | Tablet | 22187 | 9/2012 |
| Hydrochlorothiazide; Losartan Potassium (PDF - 113KB)Revised | Final | Oral | Tablet | 20387 | 9/2012 |
| Lopinavir; Ritonavir (PDF - 21KB)Revised | Draft | Oral | Capsule | 21226 | 9/2012 |
| Lopinavir; Ritonavir (PDF - 18KB)Revised | Draft | Oral | Tablet | 21906 | 9/2012 |
| Phytonadione (PDF - 27KB)Revised | Draft | Oral | Tablet | 10104 | 9/2012 |
| Phytonadione (PDF - 34KB) Revised | Final | Injectable | Injection | 9/2012 | |
| Propranolol HCl (PDF -37KB)Revised | Draft | Oral | Tablet | 16418 | 9/2012 |
| Sapropterin Dihydrochloride (PDF - 18KB)Revised | Draft | Oral | Tablet | 22181 | 9/2012 |
| Sumatriptan (PDF - (19KB)Revised | Draft | Nasal | Spray | 20626 | 9/2012 |
| Tadalafil (PDF - 33KB)Revised | Draft | Oral | Tablet | 21368 | 9/2012 |
| Theophylline (PDF - 18KB)Revised | Draft | Oral | Capsule, Extended Release | 9/2012 | |
| Tolterodine Tartrate (PDF - 19KB)Revised | Draft | Oral | Tablet, Extended Release | 21228 | 9/2012 |
| Topiramate (PDF - 17KB) Revised |
Draft | Oral | Capsule, Sprinkle | 20844 | 9/2012 |
| Trazodone HCl (PDF - 50KB)Revised | Draft | Oral | Tablet, Extended Release | 22411 | 9/2012 |
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