TOPIRAMATE - 52959-994-02 - (topiramate)

Alphabetical Index


Drug Information of TOPIRAMATE

Product NDC: 52959-994
Proprietary Name: TOPIRAMATE
Non Proprietary Name: topiramate
Active Ingredient(s): 50    mg/1 & nbsp;   topiramate
Administration Route(s): ORAL
Dosage Form(s): TABLET
Coding System: National Drug Codes(NDC)

Labeler Information of TOPIRAMATE

Product NDC: 52959-994
Labeler Name: H.J. Harkins Company, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA079153
Marketing Category: ANDA
Start Marketing Date: 20090327

Package Information of TOPIRAMATE

Package NDC: 52959-994-02
Package Description: 120 TABLET in 1 BOTTLE (52959-994-02)

NDC Information of TOPIRAMATE

NDC Code 52959-994-02
Proprietary Name TOPIRAMATE
Package Description 120 TABLET in 1 BOTTLE (52959-994-02)
Product NDC 52959-994
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name topiramate
Dosage Form Name TABLET
Route Name ORAL
Start Marketing Date 20090327
Marketing Category Name ANDA
Labeler Name H.J. Harkins Company, Inc.
Substance Name TOPIRAMATE
Strength Number 50
Strength Unit mg/1
Pharmaceutical Classes Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]

Complete Information of TOPIRAMATE


General Information