Topiramate

Product NDC
47335-711
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
47335-711-08100 TABLET, FILM COATED in 1 BOTTLE (47335-711-08) 20141215NoHistorical
47335-711-13500 TABLET, FILM COATED in 1 BOTTLE (47335-711-13) 20141215NoHistorical
47335-711-181000 TABLET, FILM COATED in 1 BOTTLE (47335-711-18) 20141215NoHistorical
47335-711-8330 TABLET, FILM COATED in 1 BOTTLE (47335-711-83) 20141215NoHistorical
47335-711-8660 TABLET, FILM COATED in 1 BOTTLE (47335-711-86) 20141215NoHistorical
47335-711-88100 TABLET, FILM COATED in 1 BOTTLE (47335-711-88) 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
e846124d-e9e6-42c7-83f1-5df170d3f70bThese 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.2025-06-12HUMAN PRESCRIPTION DRUG LABEL25
484c132f-3d3d-4218-b22f-82e9b56cc2f4These 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 Prepack2024-08-28HUMAN PRESCRIPTION DRUG LABEL18
907c4230-257e-45fd-e053-2995a90a9a66TOPIRAMATEDirect_Rx2023-01-12HUMAN PRESCRIPTION DRUG LABEL3
907a9929-4e0f-2f14-e053-2a95a90a244fTOPIRAMATEDirect_Rx2023-01-12HUMAN PRESCRIPTION DRUG LABEL2
7d6752ce-7a56-4b04-ab15-cbd40aa5cc94These 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 LP2019-11-01HUMAN PRESCRIPTION DRUG LABEL3
35bd4587-6e8a-13a1-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.2016-06-20HUMAN PRESCRIPTION DRUG LABEL1