topiramate - 0245-0709-60 - (topiramate)

Alphabetical Index


Drug Information of topiramate

Product NDC: 0245-0709
Proprietary Name: topiramate
Non Proprietary Name: topiramate
Active Ingredient(s): 100    mg/1 & nbsp;   topiramate
Administration Route(s): ORAL
Dosage Form(s): TABLET, COATED
Coding System: National Drug Codes(NDC)

Labeler Information of topiramate

Product NDC: 0245-0709
Labeler Name: Upsher-Smith Laboratories, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA078499
Marketing Category: ANDA
Start Marketing Date: 20110502

Package Information of topiramate

Package NDC: 0245-0709-60
Package Description: 60 TABLET, COATED in 1 BOTTLE (0245-0709-60)

NDC Information of topiramate

NDC Code 0245-0709-60
Proprietary Name topiramate
Package Description 60 TABLET, COATED in 1 BOTTLE (0245-0709-60)
Product NDC 0245-0709
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name topiramate
Dosage Form Name TABLET, COATED
Route Name ORAL
Start Marketing Date 20110502
Marketing Category Name ANDA
Labeler Name Upsher-Smith Laboratories, Inc.
Substance Name TOPIRAMATE
Strength Number 100
Strength Unit mg/1
Pharmaceutical Classes Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]

Complete Information of topiramate


General Information