topiramate

Product NDC
83008-011
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA090162
Marketing category
ANDA
Substance
TOPIRAMATE
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
83008-011-3030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (83008-011-30) 2023-03-242026-08-31NoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
topiramateQuality Care Products, LLC2024-12-19HUMAN PRESCRIPTION DRUG LABEL5