Drugs

Bioequivalence Recommendations for Specific Products: Active Ingredients Starting with 'U'

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)
Date
Recommended

 

Ulipristal Acetate (PDF - KB)

Draft  Oral Tablet 22474 12/2012
Ursodiol (PDF - 29KB) Draft Oral Capsule 19594 2/2010
Ursodiol (PDF - 17KB) Draft Oral Tablet 20675 7/2008

 

Page Last Updated: 01/06/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.