← FDA Drug Approvals (Drugs@FDA)

BINIMETINIB

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC PHARMS LTD · Approved 2026-06-18

Drug application

FDA Application #

ANDA217678

Application type

Abbreviated New Drug Application (Generic)

Brand name

BINIMETINIB

Generic name

Binimetinib

Active ingredients

BINIMETINIB

Dosage form

TABLET

Route

ORAL

Marketing status

None (Tentative Approval)

Sponsor

ALEMBIC PHARMS LTD

First approval

2026-06-18

Source

Authoritative

Drugs@FDA application overview

Machine

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