Topiramate

Product NDC
47335-710
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
47335-710-08100 TABLET, FILM COATED in 1 BOTTLE (47335-710-08) 20141215NoHistorical
47335-710-13500 TABLET, FILM COATED in 1 BOTTLE (47335-710-13) 20141215NoHistorical
47335-710-181000 TABLET, FILM COATED in 1 BOTTLE (47335-710-18) 20141215NoHistorical
47335-710-8330 TABLET, FILM COATED in 1 BOTTLE (47335-710-83) 20141215NoHistorical
47335-710-8660 TABLET, FILM COATED in 1 BOTTLE (47335-710-86) 20141215NoHistorical
47335-710-88100 TABLET, FILM COATED in 1 BOTTLE (47335-710-88) 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
1b847969-2124-4350-94b0-ef5ba707673bThese 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 LABEL24
ffaacad8-4594-45a8-b292-02a84cd0c35bThese 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
9ddb8451-a455-87ec-e053-2995a90a5e5eThese 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: 1996NuCare Pharmaceuticals,Inc.2024-06-20HUMAN PRESCRIPTION DRUG LABEL3
8bd03bb2-3b9b-4707-a9a4-5618ddc3832fThese 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 LP2023-07-01HUMAN PRESCRIPTION DRUG LABEL1
6f2dcfd9-b4c2-4c06-abe5-8616632e525fThese 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
3ac13777-45fb-45c2-84b8-d56aad796140These 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.2016-06-20HUMAN PRESCRIPTION DRUG LABEL4