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)
Type Route of Administration Dosage Form RLD Application Number
(link to Orange Book)


Ulipristal Acetate (PDF - KB)

Draft  Oral Tablet 22474 12/2012

Umeclidinium bromide (PDF - 105KB)/p>

Draft Inhalation Powder 205382 10/2016

Uridine triacetate (PDF - 47KB)

Draft Oral Granules



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


Page Last Updated: 08/15/2017
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