Topiramate - 0904-6016-04 - (topiramate)

Alphabetical Index


Drug Information of Topiramate

Product NDC: 0904-6016
Proprietary Name: Topiramate
Non Proprietary Name: topiramate
Active Ingredient(s): 25    mg/1 & nbsp;   topiramate
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED
Coding System: National Drug Codes(NDC)

Labeler Information of Topiramate

Product NDC: 0904-6016
Labeler Name: Major Pharmaceuticals
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA076311
Marketing Category: ANDA
Start Marketing Date: 20090610

Package Information of Topiramate

Package NDC: 0904-6016-04
Package Description: 30 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0904-6016-04)

NDC Information of Topiramate

NDC Code 0904-6016-04
Proprietary Name Topiramate
Package Description 30 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0904-6016-04)
Product NDC 0904-6016
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name topiramate
Dosage Form Name TABLET, FILM COATED
Route Name ORAL
Start Marketing Date 20090610
Marketing Category Name ANDA
Labeler Name Major Pharmaceuticals
Substance Name TOPIRAMATE
Strength Number 25
Strength Unit mg/1
Pharmaceutical Classes Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]

Complete Information of Topiramate


General Information