Active ingredient
Afatinib
6 finished FDA listings contain Afatinib as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- AFATINIB, AFATINIB DIMALEATE
- Dosage forms
- Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 2
- Strengths listed
- 20 mg/1 · 30 mg/1 · 40 mg/1
- Brand names in FDA listings
- Gilotrif
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1430438
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 201292 | BOEHRINGER INGELHEIM | 2013-07-12 | 3 |
| ANDA 210750 | HETERO LABS LTD V | 2026-07-14 | 3 |
Official labeling on DailyMed
- AFATINIB (AFATINIB) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] · version 1 · 2026-09-04
- GILOTRIF (AFATINIB) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] · version 20 · 2025-11-19
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.