Active ingredient
Erlotinib
30 finished FDA listings contain Erlotinib as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ERLOTINIB, ERLOTINIB HYDROCHLORIDE
- Dosage forms
- Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 10
- Strengths listed
- 100 mg/1 · 150 mg/1 · 25 mg/1
- Brand names in FDA listings
- Erlotinib
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 337525
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 |
|---|---|---|---|
| ANDA 091059 | TEVA PHARMS USA INC | 2015-08-28 | 3 |
| ANDA 210300 | SUN PHARM | 2019-11-05 | 3 |
| ANDA 211960 | ADAPTIS | 2019-11-05 | 3 |
| ANDA 213065 | ZYDUS PHARMS | 2020-04-16 | 6 |
| ANDA 214366 | MSN | 2021-05-10 | 3 |
| ANDA 214719 | ALEMBIC | 2021-07-08 | 6 |
| ANDA 216342 | EUGIA PHARMA | 2022-06-22 | 3 |
| ANDA 209267 | HETERO LABS LTD V | 2024-05-24 | 3 |
Official labeling on DailyMed
- ERLOTINIB TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] · version 3 · 2024-12-02
- ERLOTINIB (ERLOTINIB) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] · version 1 · 2024-07-10
- ERLOTINIB HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] · version 3 · 2024-06-12
- ERLOTINIB TABLET [ZYDUS PHARMACEUTICALS USA INC.] · version 3 · 2023-10-11
- ERLOTINIB HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.] · version 4 · 2023-02-20
- ERLOTINIB TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] · version 1 · 2022-06-30
- ERLOTINIB TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] · version 7 · 2021-12-09
- ERLOTINIB HYDROCHLORIDE TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC] · version 1 · 2021-05-13
- ERLOTINIB (ERLOTINIB HYDROCHLORIDE) TABLET, FILM COATED [ARMAS PHARMACEUTICALS INC.] · version 1 · 2019-11-12
- ERLOTINIB (ERLOTINIB HYDROCHLORIDE) TABLET, FILM COATED [ARMAS PHARMACEUTICALS INC.] · version 1 · 2019-11-12
- ERLOTINIB (ERLOTINIB HYDROCHLORIDE) TABLET, FILM COATED [ARMAS PHARMACEUTICALS INC.] · version 1 · 2019-11-12
- ERLOTINIB TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 3 · 2019-11-06
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.