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 [Total count 1067]
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 - December 2012 ( 10 New;  13 Revision) updated 12/20/2012 

Active Ingredient (link to Specific Guidance)	Type	Route of Administration	Dosage Form	RLD Application Number (link to Orange Book)	Date Recommended
Abiraterone Acetate (PDF - 21KB)	Draft	Oral	Tablet	202379	12/2012
Albendazole (PDF - 24KB)	Draft	Oral	Tablet	20666	12/2012
Amlodipine Besylate, Hydrochlorothiazide, Olmesartan Medoxomil (PDF - 25KB)	Draft	Oral	Tablet	200175	12/2012
Clindamycin Phosphate; Tretinoin (PDF -138 KB)	Draft	Topical	Gel	50802 50803	12/2012
Clorazepate Dipotassium (PDF - 67KB)	Draft	Oral	Tablet	17105	12/2012
Ferumoxytol (PDF -33KB)	Draft	Intravenous	Injection	22180	12/2012
Gabapentin (PDF - 14KB)	Draft	Oral	Tablet	22544	12/2012
Piroxicam (PDF - 22KB)	Draft	Oral	Capsule	18147	12/2012
Sodium phosphate dibasic anhydrous & sodium phosphate monobasic monohydrate (PDF - 30KB)	Draft	Oral	Tablet	021097 079247 021892	12/2012
Ulipristal Acetate (PDF - KB)	Draft	Oral	Tablet	22474	12/2012

 

Revisions
Active Ingredient (link to Specific Guidance)	Type	Route of Administration	Dosage Form	RLD Application Number (link to Orange Book)	Date Recommended
Desmopressin Acetate (PDF-33KB)Revised	Draft	Oral	Tablet	19955	12/2012
Diflunisal (PDF-15KB)	Draft	Oral	Tablet	73673Revised	12/2012
Dipyridamole (PDF-41KB)Revised	Draft	Oral	Tablet	12836	12/2012
Hydrochlorothiazide; Lisinopril (PDF - 24KB) Revised	Draft	Oral	Tablet	19888	12/2012
Hydrochlorothiazide; Losartan Potassium (PDF - 113KB)Revised	Draft	Oral	Tablet	20387	12/2012
Liothyronine Sodium (PDF - 48KB)Revised	Draft	Oral	Tablet	10379	12/2012
Phenoxybenzamine (PDF - 15KB)Revised	Draft	Oral	Capsule	08708	12/2012
Quinine Sulfate (PDF - 18KB)Revised	Draft	Oral	Capsule	21799	12/2012
Risedronate Sodium (PDF - 40KB)>Revised	Draft	Oral	Tablet, Delayed Release	22560	12/2012
Tacrolimus (PDF - 16KB)Revised	Draft	Oral	Capsule	50708	12/2012
Thalidomide (PDF -20KB)Revised	Draft	Oral	Capsule	20785 21430	12/2012
Tinidazole (PDF - 26KB)Revised	Draft	Oral	Tablet	21618	12/2012
Warfarin Sodium (PDF - 95KB) Revised	Draft	Oral	Tablet	09218	12/2012