← FDA Drug Approvals (Drugs@FDA)

MESALAMINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ENCUBE · Approved 2023-05-30

Drug application

FDA Application #

ANDA216941

Application type

Abbreviated New Drug Application (Generic)

Brand name

MESALAMINE

Generic name

MESALAMINE

Active ingredients

MESALAMINE

Dosage form

ENEMA

Route

RECTAL

Marketing status

Prescription

Sponsor

ENCUBE

Manufacturer

Encube Ethicals, Inc.

First approval

2023-05-30

Source

Authoritative

Drugs@FDA application overview

Machine

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