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Package Insert and Label Information: TOPIRAMATE

By ScinoPharm Taiwan Ltd. | Last revised: 24 August 2009

TOPIRAMATE — topiramate powder
ScinoPharm Taiwan Ltd.

Note: Product label of topiramate USP drug substance is updated with the expiration period of two years for micronized product per the request from FDA deficiency letter.
Product Label
(click image for full-size original)

Product Label
TOPIRAMATE
topiramate powder
Product Information
Product Type BULK INGREDIENT Item Code (Source) NDC:65129-1024
Route of Administration NOT APPLICABLE DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOPIRAMATE (TOPIRAMATE) TOPIRAMATE 1 in 1 kg
Product Characteristics
Color white (white ) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65129-1024-0 50 kg in 1 BAG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
bulk ingredient 12/26/2002
Labeler — ScinoPharm Taiwan Ltd. (657484726)
Registrant — ScinoPharm Taiwan Ltd. (657484726)
Establishment
Name Address ID/FEI Operations
ScinoPharm Taiwan Ltd. 657484726 manufacture

Revised: 08/2009 ScinoPharm Taiwan Ltd.

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