Last Updated: May 3, 2026

Details for New Drug Application (NDA): 017581

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NDA 017581 describes NAPROSYN, which is a drug marketed by Atnahs Pharma Us and is included in two NDAs. It is available from one supplier. Additional details are available on the NAPROSYN profile page.

The generic ingredient in NAPROSYN is naproxen. There are forty-two drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the naproxen profile page.

Summary for 017581

Tradename:	NAPROSYN
Applicant:	Atnahs Pharma Us
Ingredient:	naproxen
Patents:	0

Medical Subject Heading (MeSH) Categories for 017581

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

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	375MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Apr 15, 1982	TE:	AB	RLD:	Yes

Expired US Patents for NDA 017581

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Atnahs Pharma Us	NAPROSYN	naproxen	TABLET;ORAL	017581-003	Approved Prior to Jan 1, 1982	⤷ Start Trial	⤷ Start Trial
Atnahs Pharma Us	NAPROSYN	naproxen	TABLET;ORAL	017581-002	Approved Prior to Jan 1, 1982	⤷ Start Trial	⤷ Start Trial
Atnahs Pharma Us	NAPROSYN	naproxen	TABLET;ORAL	017581-002	Approved Prior to Jan 1, 1982	⤷ Start Trial	⤷ Start Trial
Atnahs Pharma Us	NAPROSYN	naproxen	TABLET;ORAL	017581-004	Apr 15, 1982	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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