Details for New Drug Application (NDA): 018965

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NDA 018965 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 018965

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

Pharmacology for NDA: 018965

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 018965

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

Suppliers and Packaging for NDA: 018965

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NAPROSYN	naproxen	SUSPENSION;ORAL	018965	NDA AUTHORIZED GENERIC	Acella Pharmaceuticals, LLC	42192-619	42192-619-16	473 mL in 1 BOTTLE (42192-619-16)
NAPROSYN	naproxen	SUSPENSION;ORAL	018965	NDA	Athena Bioscience, LLC	71511-701	71511-701-16	473 mL in 1 BOTTLE, PLASTIC (71511-701-16)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	25MG/ML
Approval Date:	Mar 23, 1987	TE:	AB	RLD:	Yes

Expired US Patents for NDA 018965

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Atnahs Pharma Us	NAPROSYN	naproxen	SUSPENSION;ORAL	018965-001	Mar 23, 1987	⤷ Sign Up	⤷ Sign Up
Atnahs Pharma Us	NAPROSYN	naproxen	SUSPENSION;ORAL	018965-001	Mar 23, 1987	⤷ Sign Up	⤷ Sign Up
Atnahs Pharma Us	NAPROSYN	naproxen	SUSPENSION;ORAL	018965-001	Mar 23, 1987	⤷ Sign Up	⤷ Sign Up
Atnahs Pharma Us	NAPROSYN	naproxen	SUSPENSION;ORAL	018965-001	Mar 23, 1987	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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