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TOPIRAMATEpowder
2014-03-14 20:54:40 来源: 作者: 【大 中 小】 浏览:381次 评论:0条

 

Note: Product label of topiramate USP drug substance is updatedwith the expiration period of two years for micronized product per the request from FDA deficiency letter.
Product Label


TOPIRAMATE
topiramate powder
Product Information
Product Type BULK INGREDIENT NDC Product Code (Source) 65129-1024
Route of Administration NOT APPLICABLE DEA Schedule  
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOPIRAMATE (TOPIRAMATE) TOPIRAMATE 1 in1kg
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color white (white ) Score  
Shape   Size  
Flavor   Imprint Code  
Contains  
Packaging
# NDC Package Description Multilevel Packaging
1 65129-1024-0 50kgIn1BAG 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
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