topiramate - 65841-652-10 - (topiramate)

Alphabetical Index


Drug Information of topiramate

Product NDC: 65841-652
Proprietary Name: topiramate
Non Proprietary Name: topiramate
Active Ingredient(s): 25    mg/1 & nbsp;   topiramate
Administration Route(s): ORAL
Dosage Form(s): CAPSULE, COATED PELLETS
Coding System: National Drug Codes(NDC)

Labeler Information of topiramate

Product NDC: 65841-652
Labeler Name: Cadila Healthcare Limited
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA078877
Marketing Category: ANDA
Start Marketing Date: 20091014

Package Information of topiramate

Package NDC: 65841-652-10
Package Description: 1000 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-652-10)

NDC Information of topiramate

NDC Code 65841-652-10
Proprietary Name topiramate
Package Description 1000 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-652-10)
Product NDC 65841-652
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name topiramate
Dosage Form Name CAPSULE, COATED PELLETS
Route Name ORAL
Start Marketing Date 20091014
Marketing Category Name ANDA
Labeler Name Cadila Healthcare Limited
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