Last Updated: November 8, 2026

Details for New Drug Application (NDA): 075337

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NDA 075337 describes NAPROXEN, which is a drug marketed by Amneal, Aurobindo Pharma, Hetero Labs Ltd Iii, Hikma, Novitium Pharma, Actavis Elizabeth, Aurobindo Pharma Usa, Fosun Pharma, Nuvo Pharms Inc, Pliva, Teva, Tp Anda Holdings, Amneal Pharms Ny, Chartwell Molecules, Dava Pharms Inc, Glenmark Pharms Ltd, Granules, Hamilton Pharms, Invagen Pharms, Ivax Sub Teva Pharms, L Perrigo Co, Pharmazone, Pharmobedient, Purepac Pharm, Roxane, Sciegen Pharms, Teva Pharms, Watson Labs, Watson Labs Teva, Zydus Pharms Usa, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Dr Reddys, Bionpharma, Catalent, Onesource, Patheon Softgels, Puracap Pharm Llc, Able, Aurobindo Pharma Ltd, Contract Pharmacal, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Granules India, Hetero Labs Ltd V, Lnk Intl Inc, Novelgenix Theraps, Perrigo, Pld Acquisitions Llc, Sandoz, Sun Pharm Inds Ltd, Yichang Humanwell, Amneal Pharms Co, Macleods Pharms, P And L, and Perrigo R And D, and is included in ninety NDAs. It is available from fifty-one suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the NAPROXEN profile page.

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

Summary for 075337

Tradename:	NAPROXEN
Applicant:	Pliva
Ingredient:	naproxen
Patents:	0

Medical Subject Heading (MeSH) Categories for 075337

Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors
Gout Suppressants

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	375MG
Approval Date:	May 26, 1999	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	500MG
Approval Date:	May 26, 1999	TE:		RLD:	No

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