Bioequivalence Recommendations for Specific Products

• Guidance for Industry: 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 [Total count 946]
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

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Newly Added Recommendations - March 2012 ( 50 New;  9 Revision) updated 3/28/2012 

Active Ingredient (link to Specific Guidance)	Type	Route of Administration	Dosage Form	RLD Application Number (link to Orange Book)	Date Recommended
Acyclovir (PDF - 39KB)	Draft	Oral	Capsule	18828	3/2012
Acyclovir (PDF - 176KB)	Draft	Topical	Ointment	18604	3/2012
Amiloride (PDF - 41KB)	Draft	Oral	Tablet	70346	3/2012
Butenafine HCl (PDF - 167KB)	Draft	Topical	Cream	20524	3/2012
Butenafine HCl (PDF - 168KB)	Draft	Topical	Cream	21307	3/2012
Butenafine HCl (PDF - 155KB)	Draft	Topical	Cream	21408	3/2012
Chlorpromazine HCl (PDF - 45KB)	Draft	Oral	Tablet	80439	3/2012
Clindamycin Phosphate (PDF -230KB)	Draft	Vaginal	Cream	50680	3/2012
Clindamycin Phosphate (PDF - 230KB)	Draft	Vaginal	Cream	50793	3/2012
Clindamycin Phosphate (PDF - 227KB)	Draft	Vaginal	Suppository	50767	3/2012
Dalfampridine (PDF - 45KB)	Draft	Oral	Tablet, Extended Release	22250	3/2012
Dexmethylphenidate HCl (PDF - 130KB)	Draft	Oral	Capsule, Extended Release	21802	3/2012
Dextromethorphan Hydrobromide; Quinidine Sulfate (PDF - 39KB)	Draft	Oral	Capsule	21879	3/2012
Diclofenac Epolamine (PDF - 595KB)	Draft	Topical	Patch	21234	3/2012
Drospirenone; Ethinyl Estradiol; Levomefolate Calcium (PDF - 52KB)	Draft	Oral	Tablet	22532 22574	3/2012
Ethinyl Estradiol; Norethindrone (PDF - 41KB)	Draft	Oral	Tablet, Chewable	22573	3/2012
Fenofibrate (PDF - 39KB)	Draft	Oral	Tablet	76433	3/2012
Fludarabine Phosphate (PDF - 33KB)	Draft	Oral	Tablet	22273	3/2012
Fulvestrant (PDF - 33KB)	Draft	Injection, Intramuscular	Solution	21344	3/2012
Glyburide (PDF - 40KB)	Draft	Oral	Tablet	20051	3/2012
Glyburide (PDF - 40KB)	Draft	Oral	Tablet	74388 17532	3/2012
Granisetron (PDF - 424KB)	Draft	Transdermal	Film, Extended Release	22198	3/2012
Iron Sucrose (PDF - 21KB)	Draft	Intravenous	Injection	21135	3/2012
Ivermectin (PDF - 23KB)	Draft	Oral	Tablet	50742	3/2012
Ketoconazole (PDF - 43KB)	Draft	Topical	Foam, Aerosol 2%	21738	3/2012
Memantine HCl (PDF - 27KB)	Draft	Oral	Capsule, Extended Release	22525	3/2012
Metformin HCl; Saxagliptin (PDF - 27KB)	Draft	Oral	Tablet, Extended Release	200678	3/2012
Naftifine HCl (PDF -68KB)	Draft	Topical	Cream	19599	3/2012
Naftifine HCl (PDF - 57KB)	Draft	Topical	Gel	19356	3/2012
Nitrofurantoin; Nitrofurantoin, Macrocrystalline (PDF - 24KB)	Draft	Oral	Capsule	20064	3/2012
Ondasetron (PDF - 24KB)	Draft	Oral	Film	22524	3/2012
Oxiconazole Nitrate (PDF - 61KB)	Draft	Topical	Cream	19828	3/2012
Oxiconazole Nitrate (PDF - 65KB)	Draft	Topical	Lotion	20209	3/2012
Pimecrolimus (PDF - 72KB)	Draft	Topical	Cream	21302	3/2012
Procarbazine HCl (PDF -27KB)	Draft	Oral	Capsule	16785	3/2012
Propylthiouracil (PDF - (19KB)	Draft	Oral	Tablet	06188	3/2012
Sumatriptan (PDF - (19KB)	Draft	Nasal	Spray	20626	3/2012
Tacrolimus (PDF - 80KB)	Draft	Topical	Ointment 0.1%	50777	3/2012
Tacrolimus (PDF - 77KB)	Draft	Topical	Ointment 0.03%	50777	3/2012
Tolvaptan (PDF - 19KB)	Draft	Oral	Tablet	22275	3/2012
Tretinoin (PDF - 117KB)	Draft	Topical	Cream	17340	3/2012
Tretinoin (PDF - 117KB)	Draft	Topical	Cream	17522	3/2012
Tretinoin (PDF - 117KB)	Draft	Topical	Cream	19049	3/2012
Tretinoin (PDF - 117KB)	Draft	Topical	Cream	90098	3/2012
Tretinoin (PDF - 116KB)	Draft	Topical	Gel	17579	3/2012
Tretinoin (PDF - 126KB)	Draft	Topical	Gel	17955	3/2012
Tretinoin (PDF - 126KB)	Draft	Topical	Gel	22070	3/2012
Tretinoin (PDF - 129KB)	Draft	Topical	Solution	16921	3/2012
Vardenafil HCl (PDF - 26KB)	Draft	Oral	Tablets, Orally Disintegrating	200179	3/2012
Vilazodone HCl (PDF - 24KB)	Draft	Oral	Tablet	22567	3/2012

 

Revisions
Active Ingredient (link to Specific Guidance)	Type	Route of Administration	Dosage Form	RLD Application Number (link to Orange Book)	Date Recommended
Benzoyl Peroxide; Clindamycin Phosphate (PDF - 325 KB)Revised	Draft	Topical	Gel	50741	3/2012
Benzoyl Peroxide; Clindamycin Phosphate (PDF - 271KB)Revised	Draft	Topical	Gel	50756	3/2012
Bosentan (PDF - 34KB)Revised	Draft	Oral	Tablet	21290	3/2012
Cholestyramine (PDF - 168KB) Revised	Draft	Oral	Powder	74557 74558	3/2012
Colesevelam HCl (PDF - 41KB)Revised	Draft	Oral	Powder, Suspension	22362	3/2012
Dexamethasone; Tobramycin (PDF-49KB)Revised	Draft	Ophthalmic	Suspension	50818	3/2012
Hydrochlorothiazide;Irbesartan (PDF - 45KB)Revised	Draft	Oral	Tablet	20758	3/2012
Loteprednol Etabonate (PDF - 58KB)Revised	Draft	Ophthalmic	Drops, suspension	20583 20803	3/2012
Paliperidone (PDF - 19KB)Revised	Draft	Oral	Tablet, Extended Release	21999	3/2012