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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 216908

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NDA 216908 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, Mylan, Bionpharma, Catalent, Patheon Softgels, Puracap Pharm Llc, Strides Pharma, 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 fifty-three 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 216908

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

Pharmacology for NDA: 216908

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 216908

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

Suppliers and Packaging for NDA: 216908

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NAPROXEN	naproxen	TABLET, DELAYED RELEASE;ORAL	216908	ANDA	TruPharma LLC	52817-380	52817-380-10	100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (52817-380-10)
NAPROXEN	naproxen	TABLET, DELAYED RELEASE;ORAL	216908	ANDA	TruPharma LLC	52817-381	52817-381-10	100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (52817-381-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	375MG
Approval Date:	May 31, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	500MG
Approval Date:	May 31, 2023	TE:	AB	RLD:	No

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