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AFATINIB

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MSN PHARMACEUTICALS INC · Approved 2026-02-18

Drug application

FDA Application #
ANDA210804
Application type
Abbreviated New Drug Application (Generic)
Brand name
AFATINIB
Generic name
Afatinib
Active ingredients
AFATINIB
Dosage form
TABLET
Route
ORAL
Marketing status
None (Tentative Approval)
Sponsor
MSN PHARMACEUTICALS INC
First approval
2026-02-18

Source

Authoritative
Drugs@FDA application overview
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