Topiramate

Product NDC
47335-707
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA090278
Marketing category
ANDA
Substance
TOPIRAMATE
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
47335-707-08100 TABLET, FILM COATED in 1 BOTTLE (47335-707-08) 20141215NoHistorical
47335-707-13500 TABLET, FILM COATED in 1 BOTTLE (47335-707-13) 20141215NoHistorical
47335-707-181000 TABLET, FILM COATED in 1 BOTTLE (47335-707-18) 20141215NoHistorical
47335-707-8330 TABLET, FILM COATED in 1 BOTTLE (47335-707-83) 20141215NoHistorical
47335-707-8660 TABLET, FILM COATED in 1 BOTTLE (47335-707-86) 20141215NoHistorical
47335-707-88100 TABLET, FILM COATED in 1 BOTTLE (47335-707-88) 20141215NoHistorical

Related DailyMed Labels

Set IDTitleManufacturerEffective dateTypeVersion
3c909a53-ae66-4b28-a741-b60bb25a69cfThese highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited2026-04-03Human Prescription Drug Label22
021005ab-6a00-40d8-9aee-20c91613b4d5These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996PD-Rx Pharmaceuticals, Inc.2025-07-17HUMAN PRESCRIPTION DRUG LABEL21
61390be3-7553-4cb5-b5da-7571ed7d4b17These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996Bryant Ranch Prepack2024-08-20HUMAN PRESCRIPTION DRUG LABEL105
e382a731-ef73-4990-bc74-ffc3a91ff3baThese highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996Proficient Rx LP2022-06-01HUMAN PRESCRIPTION DRUG LABEL4
969706ca-698c-4899-977b-e807adf3ad10These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996A-S Medication Solutions2021-04-16Human Prescription Drug Label6
77f62dd7-0b58-03a9-e053-2a91aa0a69f5These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996Denton Pharma, Inc. DBA Northwind Pharmaceuticals2020-12-30HUMAN PRESCRIPTION DRUG LABEL3
7d62746b-f8da-32de-e053-2a91aa0add64These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996medsource pharmaceuticals2018-12-19HUMAN PRESCRIPTION DRUG LABEL2
35d19524-1c95-64e5-e054-00144ff88e88These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral use Initial U.S. Approval: 1996Apotheca Inc.2016-06-21HUMAN PRESCRIPTION DRUG LABEL3