FDA.report

Naproxen Sodium (NSAID)

Product NDC
53746-192
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA079096
Marketing category
ANDA
Substance
NAPROXEN SODIUM
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
53746-192-05500 TABLET in 1 BOTTLE (53746-192-05) 2009-11-25NoHistorical
53746-192-088 TABLET in 1 VIAL (53746-192-08) 2009-11-25NoHistorical
53746-192-2424 TABLET in 1 BOTTLE (53746-192-24) 2009-11-25NoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Naproxen Sodium Tablets, USP Pain Reliever/ Fever Reducer (NSAID) 220 mgAmneal Pharmaceuticals of New York LLC2023-12-31HUMAN OTC DRUG LABEL13
Naproxen Sodium Tablets, USP Pain Reliever/ Fever Reducer (NSAID) 220 mgPhysicians Total Care, Inc.2010-07-16HUMAN OTC DRUG LABEL2