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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 021920

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NDA 021920 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 021920

Tradename:	NAPROXEN SODIUM
Applicant:	Bionpharma
Ingredient:	naproxen sodium
Patents:	5

Pharmacology for NDA: 021920

Mechanism of Action	Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 021920

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NAPROXEN SODIUM	naproxen sodium	CAPSULE;ORAL	021920	NDA	Bayer HealthCare LLC.	0280-6080	0280-6080-01	1 BOTTLE in 1 CARTON (0280-6080-01) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE
NAPROXEN SODIUM	naproxen sodium	CAPSULE;ORAL	021920	NDA	Bayer HealthCare LLC.	0280-6080	0280-6080-02	2 BOTTLE in 1 PACKAGE, COMBINATION (0280-6080-02) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CAPSULE;ORAL			Strength	EQ 200MG BASE
Approval Date:	Feb 17, 2006	TE:		RLD:	Yes
Patent:	10,022,344	Patent Expiration:	Mar 3, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TEMPORARY REDUCTION OF FEVER
Patent:	10,022,344	Patent Expiration:	Mar 3, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TEMPORARY RELIEF OF MINOR ACHES AND PAINS
Patent:	10,028,925	Patent Expiration:	Mar 3, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TEMPORARY REDUCTION OF FEVER

Expired US Patents for NDA 021920

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bionpharma	NAPROXEN SODIUM	naproxen sodium	CAPSULE;ORAL	021920-001	Feb 17, 2006	9,693,978	⤷ Get Started Free
Bionpharma	NAPROXEN SODIUM	naproxen sodium	CAPSULE;ORAL	021920-001	Feb 17, 2006	10,028,925	⤷ Get Started Free
Bionpharma	NAPROXEN SODIUM	naproxen sodium	CAPSULE;ORAL	021920-001	Feb 17, 2006	10,022,344	⤷ Get Started Free
Bionpharma	NAPROXEN SODIUM	naproxen sodium	CAPSULE;ORAL	021920-001	Feb 17, 2006	11,090,280	⤷ Get Started Free
Bionpharma	NAPROXEN SODIUM	naproxen sodium	CAPSULE;ORAL	021920-001	Feb 17, 2006	9,693,979	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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