FDA.report

Pantoprazole Sodium

Product NDC
0904-7458
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA202038
Marketing category
ANDA
Substance
PANTOPRAZOLE SODIUM
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
0904-7458-61100 BLISTER PACK in 1 CARTON (0904-7458-61) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK2024-10-07NoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000Cardinal Health 107, LLC2026-01-22HUMAN PRESCRIPTION DRUG LABEL6
These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000Major Pharmaceuticals2026-01-08HUMAN PRESCRIPTION DRUG LABEL6
These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000Cardinal Health 107, LLC2025-02-25HUMAN PRESCRIPTION DRUG LABEL4
These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000Major Pharmaceuticals2024-10-07HUMAN PRESCRIPTION DRUG LABEL4