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NAPRELAN

NDA · New Drug Application · Sponsor: TWI PHARMS · Approved 1996-01-05

Drug application

FDA Application #

NDA020353

Application type

New Drug Application

Brand name

NAPRELAN

Generic name

NAPROXEN SODIUM

Active ingredients

NAPROXEN SODIUM

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

TWI PHARMS

Manufacturer

Upsher-Smith Laboratories, LLC

First approval

1996-01-05

Source

Authoritative

Drugs@FDA application overview

Machine

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