Details for New Drug Application (NDA): 018164

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NDA 018164 describes ANAPROX DS, which is a drug marketed by Atnahs Pharma Us and is included in one NDA. It is available from two suppliers. Additional details are available on the ANAPROX DS profile page.

The generic ingredient in ANAPROX DS is naproxen sodium. There are forty-two drug master file entries for this compound. One hundred and thirty-three suppliers are listed for this compound. Additional details are available on the naproxen sodium profile page.

Summary for 018164

Tradename:	ANAPROX DS
Applicant:	Atnahs Pharma Us
Ingredient:	naproxen sodium
Patents:	0

Pharmacology for NDA: 018164

Mechanism of Action	Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 018164

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ANAPROX	naproxen sodium	TABLET;ORAL	018164	NDA	Canton Laboratories	69437-203	69437-203-01	100 TABLET in 1 BOTTLE, PLASTIC (69437-203-01)
ANAPROX	naproxen sodium	TABLET;ORAL	018164	NDA	Woodward Pharma Services LLC	69784-550	69784-550-01	100 TABLET in 1 BOTTLE, PLASTIC (69784-550-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 500MG BASE
Approval Date:	Sep 30, 1987	TE:	AB	RLD:	Yes

Expired US Patents for NDA 018164

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Atnahs Pharma Us	ANAPROX	naproxen sodium	TABLET;ORAL	018164-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Atnahs Pharma Us	ANAPROX DS	naproxen sodium	TABLET;ORAL	018164-003	Sep 30, 1987	⤷ Sign Up	⤷ Sign Up
Atnahs Pharma Us	ANAPROX DS	naproxen sodium	TABLET;ORAL	018164-003	Sep 30, 1987	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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