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

Product-Specific Guidances 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)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Ketoconazole (PDF - 244KB) Draft TopicalGel219466/2012
Ketoconazole (PDF - 73KB)DraftTopicalCream0190843/2010
Ketoconazole (PDF - 43KB) RevisedDraftTopicalFoam, Aerosol 2%2173812/2014
Ketoconazole (PDF - 84KB)DraftTopical, suspensionShampoo203109/2012
Ketoconazole USP, 2% (PDF - 43KB)DraftTopicalShampoo (Suspension)199277/2008
Ketorolac Tromethamine (PDF - 25KB)DraftNasalSpray, Metered223824/2013
Ketorolac Tromethamine (PDF - 16KB)DraftOralTablet0196457/2008


Page Last Updated: 08/09/2017
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