Individual Product Bioequivalence Recommendations

• Draft Guidance for Industry: Bioequivalence Recommendations for Specific Products (PDF - 45 KB) (Issued May 2007)

 

Dissolutions Methods Database

 

Individual Product Bioequivalence Recommendations Arranged by Active Ingredient [Total count 458]
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 - October 2009 (18) updated 10/30/2009

 

 

 

Active Ingredient (link to Specific Guidance)	Type	Route of Administration	Dosage Form	RLD Application Number (link to Orange Book)	Date Recommended
Budesonide	Draft	Oral	Capsule	21324	10/2009
Clotrimazole	Draft	Vaginal	Cream	18052	10/2009
Clotrimazole	Draft	Vaginal	Cream	20574	10/2009
Clotrimazole	Draft	Vaginal	Tablet	17717	10/2009
Clotrimazole	Draft	Vaginal	Tablet	20525	10/2009
Diclofenac Sodium	Draft	Oral	Tablet, Delayed Release	19201 74376	10/2009
Diclofenac Sodium	Draft	Oral	Tablet, Extended Release	20254	10/2009
Ethinyl Estradiol; Norethindrone Acetate	Draft	Oral	Tablet	17355 17875 17354 17876 21871	10/2009
Ethinyl Estradiol; Norgestrel	Draft	Oral	Tablet	75406 75288	10/2009
Ethinyl Estradiol; Ethynodiol Diacetate	Draft	Oral	Tablet	72723 72721	10/2009
Fexofenadine HCl; Pseudoephedrine HCl	Draft	Oral	Tablet, Extended Release	20786 21704	10/2009
Metformin HCl; Repaglinide	Draft	Oral	Tablet	22386	10/2009
Miconazole Nitrate	Draft	Vaginal	Cream	17450	10/2009
Miconazole Nitrate	Draft	Vaginal	Cream	20827	10/2009
Miconazole Nitrate	Draft	Vaginal	Suppository	18520	10/2009
Miconazole Nitrate	Draft	Vaginal	Suppository	18888	10/2009
Niacin	Draft	Oral	Tablet, Extended Release	20381	10/2009
Norethindrone	Draft	Oral	Tablet	17060	10/2009