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ROWASA

NDA · New Drug Application · Sponsor: MYLAN SPECIALITY LP · Approved 1987-12-24

Drug application

FDA Application #

NDA019618

Application type

New Drug Application

Brand name

ROWASA

Generic name

MESALAMINE

Active ingredients

MESALAMINE

Dosage form

ENEMA

Route

RECTAL

Marketing status

Prescription

Sponsor

MYLAN SPECIALITY LP

Manufacturer

ANI Pharmaceuticals, Inc.

First approval

1987-12-24

Source

Authoritative

Drugs@FDA application overview

Machine

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