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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 078432

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NDA 078432 describes NAPROXEN SODIUM, which is a drug marketed by Bionpharma, Catalent, Onesource Specialty, Patheon Softgels, Puracap Pharm Llc, Actavis Labs Fl Inc, Able, Adaptis, 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 Inc, 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 078432

Tradename:	NAPROXEN SODIUM
Applicant:	Amneal Pharms Ny
Ingredient:	naproxen sodium
Patents:	0

Pharmacology for NDA: 078432

Mechanism of Action	Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 078432

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	078432	ANDA	AvPAK	50268-592	50268-592-15	50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-592-15) / 1 TABLET in 1 BLISTER PACK (50268-592-11)
NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	078432	ANDA	Proficient Rx LP	63187-121	63187-121-60	60 TABLET in 1 BOTTLE (63187-121-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 250MG BASE
Approval Date:	Apr 25, 2007	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 500MG BASE
Approval Date:	Apr 25, 2007	TE:		RLD:	No

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