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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 214463

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NDA 214463 describes NAPROXEN SODIUM, which is a drug marketed by Bionpharma, Catalent, Onesource Specialty, Patheon Softgels, Puracap Pharm Llc, Actavis Labs Fl Inc, Able, 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, 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 214463

Tradename:	NAPROXEN SODIUM
Applicant:	Patheon Softgels
Ingredient:	naproxen sodium
Patents:	0

Pharmacology for NDA: 214463

Mechanism of Action	Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 214463

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NAPROXEN SODIUM	naproxen sodium	CAPSULE;ORAL	214463	ANDA	Bayer Healthcare LLC	0280-0105	0280-0105-01	120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0280-0105-01)
NAPROXEN SODIUM	naproxen sodium	CAPSULE;ORAL	214463	ANDA	Bayer Healthcare LLC	0280-0105	0280-0105-02	160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0280-0105-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CAPSULE;ORAL			Strength	EQ 200MG BASE
Approval Date:	Jan 10, 2023	TE:		RLD:	No

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