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Last Updated: April 19, 2024

Details for New Drug Application (NDA): 020353

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NDA 020353 describes NAPRELAN, which is a drug marketed by Twi Pharms and is included in one NDA. It is available from three suppliers. Additional details are available on the NAPRELAN profile page.

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

Summary for 020353

Tradename:	NAPRELAN
Applicant:	Twi Pharms
Ingredient:	naproxen sodium
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020353

Mechanism of Action	Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 020353

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353	NDA AUTHORIZED GENERIC	Alvogen Inc.	47781-153	47781-153-01	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47781-153-01)
NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353	NDA AUTHORIZED GENERIC	Alvogen Inc.	47781-154	47781-154-75	75 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47781-154-75)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 375MG BASE
Approval Date:	Jan 5, 1996	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 500MG BASE
Approval Date:	Jan 5, 1996	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 750MG BASE
Approval Date:	Jan 5, 1996	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020353

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Twi Pharms	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-003	Jan 5, 1996	⤷ Try a Trial	⤷ Try a Trial
Twi Pharms	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-001	Jan 5, 1996	⤷ Try a Trial	⤷ Try a Trial
Twi Pharms	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-002	Jan 5, 1996	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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