Drugs

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

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)
Date
Recommended

 

Ulipristal Acetate (PDF - KB)

Draft OralTablet2247412/2012

Umeclidinium bromide (PDF - 105KB)/p>

DraftInhalationPowder20538210/2016
Ursodiol (PDF - 29KB)DraftOralCapsule195942/2010
Ursodiol (PDF - 17KB)DraftOralTablet206757/2008

 

Page Last Updated: 05/16/2017
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