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Last Updated: April 12, 2025

Details for New Drug Application (NDA): 212705

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NDA 212705 describes NAPROXEN, which is a drug marketed by Amneal, Hetero Labs Ltd Iii, Hikma, Novitium Pharma, Actavis Elizabeth, Aurobindo Pharma Usa, Fosun Pharma, Nuvo Pharms Inc, Pliva, Teva, Trupharma, Adaptis, Amneal Pharms Ny, Aurobindo Pharma, Chartwell Molecules, Dava Pharms Inc, Glenmark Pharms Ltd, Granules, Hamilton Pharms, Hikma Intl Pharms, Invagen Pharms, Ivax Sub Teva Pharms, L Perrigo Co, Norvium Bioscience, 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, Patheon Softgels, Puracap Pharm Llc, Strides Softgels, 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 eighty-nine NDAs. It is available from forty-nine 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. Ten suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.

Summary for 212705

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

Pharmacology for NDA: 212705

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 212705

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

Suppliers and Packaging for NDA: 212705

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NAPROXEN	naproxen	SUSPENSION;ORAL	212705	ANDA	Amneal Pharmaceuticals NY LLC	69238-1730	69238-1730-2	473 mL in 1 BOTTLE (69238-1730-2)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	25MG/ML
Approval Date:	Jul 31, 2020	TE:	AB	RLD:	No

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