← FDA Drug Approvals (Drugs@FDA)

MESALAMINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: DIFGEN PHARMS · Approved 2026-03-10

Drug application

FDA Application #

ANDA219997

Application type

Abbreviated New Drug Application (Generic)

Brand name

MESALAMINE

Generic name

Mesalamine

Active ingredients

MESALAMINE

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

DIFGEN PHARMS

First approval

2026-03-10

Source

Authoritative

Drugs@FDA application overview

Machine

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