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ASACOL

NDA · New Drug Application · Sponsor: APIL · Approved 1992-01-31

Drug application

FDA Application #

NDA019651

Application type

New Drug Application

Brand name

ASACOL

Generic name

Mesalamine

Active ingredients

MESALAMINE

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

Marketing status

Discontinued

Sponsor

APIL

First approval

1992-01-31

Source

Authoritative

Drugs@FDA application overview

Machine

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