Last Updated: May 3, 2026

Details for New Drug Application (NDA): 091353

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NDA 091353 describes NAPROXEN SODIUM, which is a drug marketed by Bionpharma, Catalent, Onesource Specialty, Patheon Softgels, Puracap Pharm Llc, Actavis Labs Fl Inc, Able, Amneal Pharms Ny, Aurobindo Pharma Ltd, Contract Pharmacal, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Granules India, Hamilton Pharms, Hetero Labs Ltd V, Hikma, Ivax Sub Teva Pharms, Lnk Intl Inc, Marksans Pharma, Novelgenix Theraps, Perrigo, Pharmobedient, Pld Acquisitions Llc, Pliva, Purepac Pharm, Roxane, Sandoz, Sciegen Pharms, Sun Pharm Inds Ltd, Teva, Teva Pharms, Watson Labs, Yichang Humanwell, Amneal Pharms Co, Corepharma, Granules, P And L, Perrigo R And D, and Aurobindo Pharma, and is included in forty-eight NDAs. It is available from one hundred and twenty-one suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the NAPROXEN SODIUM profile page.

The generic ingredient in NAPROXEN SODIUM is naproxen sodium; pseudoephedrine hydrochloride. There are forty-two drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.

Summary for 091353

Tradename:	NAPROXEN SODIUM
Applicant:	Granules India
Ingredient:	naproxen sodium
Patents:	0

Pharmacology for NDA: 091353

Mechanism of Action	Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 091353

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	091353	ANDA	TARGET CORPORATION	11673-764	11673-764-05	50 TABLET in 1 BOTTLE (11673-764-05)
NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	091353	ANDA	TARGET CORPORATION	11673-764	11673-764-09	90 TABLET in 1 BOTTLE (11673-764-09)

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	220MG
Approval Date:	Sep 20, 2011	TE:		RLD:	No

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