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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 216504

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NDA 216504 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, Adaptis, Amneal Pharms Ny, Chartwell Molecules, Dava Pharms Inc, Glenmark Pharms Ltd, Granules, Hamilton Pharms, Hikma Intl Pharms, Invagen Pharms, Ivax Sub Teva Pharms, L Perrigo Co, Pharmobedient, Purepac Pharm, Roxane, Sciegen Pharms Inc, Teva Pharms, Watson Labs, Watson Labs Teva, Zydus Pharms Usa, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Dr Reddys, Bionpharma, Catalent, Onesource Specialty, 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, Marksans Pharma, Novelgenix Theraps, Perrigo, Pld Acquisitions Llc, Sandoz, Sun Pharm Inds Ltd, Yichang Humanwell, Amneal Pharms Co, Corepharma, P And L, and Perrigo R And D, and is included in ninety NDAs. It is available from fifty-two 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 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 216504

Tradename:	NAPROXEN
Applicant:	Aurobindo Pharma
Ingredient:	naproxen
Patents:	0

Pharmacology for NDA: 216504

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 216504

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

Suppliers and Packaging for NDA: 216504

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NAPROXEN	naproxen	SUSPENSION;ORAL	216504	ANDA	Aurobindo Pharma Limited	59651-528	59651-528-47	1 BOTTLE in 1 CARTON (59651-528-47) / 473 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	25MG/ML
Approval Date:	Oct 3, 2025	TE:	AB	RLD:	No

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