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GOMEKLI

NDA · New Drug Application · Sponsor: SPRINGWORKS · Approved 2025-02-11

Drug application

FDA Application #

NDA219379

Application type

New Drug Application

Brand name

GOMEKLI

Generic name

MIRDAMETINIB

Active ingredients

MIRDAMETINIB

Dosage form

TABLET, FOR SUSPENSION

Route

ORAL

Marketing status

Prescription

Sponsor

SPRINGWORKS

Manufacturer

SpringWorks Therapeutics, Inc.

First approval

2025-02-11

Source

Authoritative

Drugs@FDA application overview

Machine

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