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Individual Product Bioequivalence Recommendations

 

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
    
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