Active ingredient
Gefitinib
5 finished FDA listings contain Gefitinib as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- GEFITINIB
- Dosage forms
- Tablet, Coated, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 5
- Strengths listed
- 250 mg/1
- Brand names in FDA listings
- Iressa
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 328134
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 206995 | ASTRAZENECA | 2015-07-13 | 1 |
| ANDA 211591 | QILU PHARM HAINAN | 2023-02-13 | 2 |
| ANDA 208913 | ACTAVIS LABS FL INC | 2023-04-26 | 1 |
| ANDA 212827 | NATCO | 2023-05-31 | 1 |
Official labeling on DailyMed
- GEFITINIB TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.] · version 6 · 2026-08-20
- GEFITINIB TABLET, FILM COATED [NATCO PHARMA USA LLC] · version 4 · 2026-03-11
- IRESSA (GEFITINIB) TABLET, COATED [ASTRAZENECA PHARMACEUTICALS LP] · version 19 · 2025-08-18
- GEFITINIB TABLET, COATED [INGENUS PHARMACEUTICALS, LLC] · version 3 · 2023-12-29
- GEFITINIB TABLET, COATED [QILU PHARMACEUTICAL CO., LTD.] · version 7 · 2023-02-23
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.