← FDA Drug Approvals (Drugs@FDA)

AFATINIB

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SANDOZ INC · Approved 2026-01-09

Drug application

FDA Application #

ANDA210703

Application type

Abbreviated New Drug Application (Generic)

Brand name

AFATINIB

Generic name

Afatinib

Active ingredients

AFATINIB

Dosage form

TABLET

Route

—

Marketing status

None (Tentative Approval)

Sponsor

SANDOZ INC

First approval

2026-01-09

Source

Authoritative

Drugs@FDA application overview

Machine

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