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PENTASA

NDA · New Drug Application · Sponsor: TAKEDA PHARMS USA · Approved 1993-05-10

Drug application

FDA Application #

NDA020049

Application type

New Drug Application

Brand name

PENTASA

Generic name

MESALAMINE

Active ingredients

MESALAMINE

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

TAKEDA PHARMS USA

Manufacturer

Takeda Pharmaceuticals America, Inc.

First approval

1993-05-10

Source

Authoritative

Drugs@FDA application overview

Machine

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