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 four suppliers. 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-eight 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

Pharmacology for NDA: 017581

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 017581

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

Suppliers and Packaging for NDA: 017581

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NAPROSYN	naproxen	TABLET;ORAL	017581	NDA	Canton Laboratories	69437-316	69437-316-01	100 TABLET in 1 BOTTLE, PLASTIC (69437-316-01)
NAPROSYN	naproxen	TABLET;ORAL	017581	NDA	Woodward Pharma Services LLC	69784-505	69784-505-01	100 TABLET in 1 BOTTLE, PLASTIC (69784-505-01)

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

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