← FDA Drug Approvals (Drugs@FDA)

MESALAMINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACTAVIS LABS FL · Approved 2018-03-23

Drug application

FDA Application #

ANDA203817

Application type

Abbreviated New Drug Application (Generic)

Brand name

MESALAMINE

Generic name

MESALAMINE

Active ingredients

MESALAMINE

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

ACTAVIS LABS FL

Manufacturer

Actavis Pharma, Inc.

First approval

2018-03-23

Source

Authoritative

Drugs@FDA application overview

Machine

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