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AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)

NDA · New Drug Application · Sponsor: VERASTEM INC · Approved 2025-05-08

Drug application

FDA Application #

NDA219616

Application type

New Drug Application

Brand name

AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)

Generic name

AVUTOMETINIB POTASSIUM AND DEFACTINIB HYDROCHLORIDE

Active ingredients

AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE

Dosage form

CAPSULE, TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

VERASTEM INC

Manufacturer

Verastem Inc.

First approval

2025-05-08

Source

Authoritative

Drugs@FDA application overview

Machine

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