Product-Specific Recommendations for Generic Drug Development: Active Ingredients Starting with 'K'

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

Active Ingredient
(link to Specific Guidance)
Type Route of Administration Dosage Form RLD Application Number
(link to Orange Book)
 Ketoconazole (PDF - 244KB)  Draft  Topical Gel 21946 6/2012
Ketoconazole (PDF - 73KB) Draft Topical Cream 75581 3/2010
Ketoconazole (PDF - 43KB) Revised Draft Topical Foam, Aerosol 2% 21738 12/2014
Ketoconazole (PDF - 84KB) Draft Topical, suspension Shampoo 20310 9/2012
Ketoconazole USP, 2% (PDF - 43KB) Draft Topical Shampoo (Suspension) 19927 7/2008
Ketorolac Tromethamine (PDF - 25KB) Draft Nasal Spray, Metered 22382 4/2013
Ketorolac Tromethamine (PDF - 16KB) Draft Oral Tablet 74761 7/2008


Page Last Updated: 08/23/2016
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