Naproxen

Product NDC
53746-190
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA075927
Marketing category
ANDA
Substance
NAPROXEN
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
53746-190-01100 TABLET in 1 BOTTLE (53746-190-01) 2010-02-18NoHistorical
53746-190-05500 TABLET in 1 BOTTLE (53746-190-05) 2010-02-18NoHistorical
53746-190-101000 TABLET in 1 BOTTLE (53746-190-10) 2010-02-18NoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976Amneal Pharmaceuticals of New York LLC | Amneal Pharmaceuticals, LLC2025-03-14HUMAN PRESCRIPTION DRUG LABEL27
40d5f084-756d-33cf-e054-00144ff8d46cRedPharm Drug, Inc.2022-01-19HUMAN PRESCRIPTION DRUG LABEL6
These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976A-S Medication Solutions2021-06-10HUMAN PRESCRIPTION DRUG LABEL34
Naproxen Tablets, USPProficient Rx LP2021-01-01HUMAN PRESCRIPTION DRUG LABEL5
These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. N A P R O X E N tablets, for oral use Initial U.S. Approval: 1976Unit Dose Services2019-01-02HUMAN PRESCRIPTION DRUG LABEL7
Naproxen Tablets, USPAvera McKennan Hospital2017-03-17HUMAN PRESCRIPTION DRUG LABEL1
Naproxen Tablets, USPPreferred Pharmaceuticals, Inc.2016-11-30HUMAN PRESCRIPTION DRUG LABEL3
Naproxen Tablets, USPBlenheim Pharmacal,Inc. | Blenheim Pharmacal, Inc.2015-05-27HUMAN PRESCRIPTION DRUG LABEL1
Naproxen Tablets, USPAphena Pharma Solutions - Tennessee, LLC2014-06-09HUMAN PRESCRIPTION DRUG LABEL3
Naproxen Tablets, USPBlenheim Pharmacal, Inc.2014-03-04HUMAN PRESCRIPTION DRUG LABEL2
Naproxen Tablets, USPAidarex Pharmaceuticals LLC2014-01-17HUMAN PRESCRIPTION DRUG LABEL1
Naproxen Tablets, USPLiberty Pharmaceuticals, Inc.2013-08-27HUMAN PRESCRIPTION DRUG LABEL1
Naproxen Tablets, USPLiberty Pharmaceuticals, Inc.2012-10-23HUMAN PRESCRIPTION DRUG LABEL1
Naproxen Tablets, USPLife Line Home Care Services, Inc.2012-02-23HUMAN PRESCRIPTION DRUG LABEL1
Naproxen Tablets, USPBlenheim Pharmacal, Inc.2010-10-06HUMAN PRESCRIPTION DRUG LABEL1
Naproxen Tablets, USPKeltman Pharmaceuticals Inc. | Sandhills Packaging2010-10-04HUMAN PRESCRIPTION DRUG LABEL2
Naproxen Tablets, USPRebel Distributors Corp.2010-02-18HUMAN PRESCRIPTION DRUG LABEL3