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AFATINIB DIMALEATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS LTD V · Approved 2026-07-14

Drug application

FDA Application #

ANDA210750

Application type

Abbreviated New Drug Application (Generic)

Brand name

AFATINIB DIMALEATE

Generic name

AFATINIB

Active ingredients

AFATINIB DIMALEATE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

HETERO LABS LTD V

Manufacturer

Camber Pharmaceuticals, Inc.

First approval

2026-07-14

Source

Authoritative

Drugs@FDA application overview

Machine

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