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APRISO

NDA · New Drug Application · Sponsor: SALIX · Approved 2008-10-31

Drug application

FDA Application #

NDA022301

Application type

New Drug Application

Brand name

APRISO

Generic name

MESALAMINE

Active ingredients

MESALAMINE

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

SALIX

Manufacturer

Teva Pharmaceuticals USA, Inc.

First approval

2008-10-31

Source

Authoritative

Drugs@FDA application overview

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