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ENZALUTAMIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA PHARMACEUTICALS USA INC · Approved 2026-02-02

Drug application

FDA Application #

ANDA218731

Application type

Abbreviated New Drug Application (Generic)

Brand name

ENZALUTAMIDE

Generic name

Enzalutamide

Active ingredients

ENZALUTAMIDE

Dosage form

TABLET

Route

—

Marketing status

None (Tentative Approval)

Sponsor

HIKMA PHARMACEUTICALS USA INC

First approval

2026-02-02

Source

Authoritative

Drugs@FDA application overview

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