Active ingredient
Eltrombopag
68 finished FDA listings contain Eltrombopag as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ELTROMBOPAG, ELTROMBOPAG CHOLINE, ELTROMBOPAG OLAMINE
- Dosage forms
- Powder, For Suspension, Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 14
- Strengths listed
- 12.5 mg/1 · 18 mg/1 · 25 mg/1 · 36 mg/1 · 50 mg/1 · 54 mg/1 · 75 mg/1 · 9 mg/1
- Brand names in FDA listings
- Alvaiz, Eltrombopag, Eltrombopag Olamine, Promacta
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 711942
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 022291 | NOVARTIS | 2008-11-20 | 4 |
| NDA 207027 | NOVARTIS | 2015-08-24 | 2 |
| NDA 216774 | TEVA PHARMS INC | 2023-11-29 | 4 |
| ANDA 216620 | ANNORA PHARMA | 2024-04-18 | 2 |
| ANDA 206788 | HETERO LABS LTD V | 2025-01-17 | 8 |
| ANDA 212884 | AMNEAL | 2026-01-14 | 12 |
| ANDA 219638 | SOMERSET THERAPS LLC | 2026-01-14 | 8 |
| ANDA 216281 | ZYDUS PHARMS | 2026-01-14 | 8 |
| ANDA 220250 | MSN | 2026-01-14 | 4 |
| ANDA 219121 | DR REDDYS | 2026-03-16 | 4 |
| ANDA 220033 | HIKMA | 2026-04-08 | 4 |
| ANDA 220660 | BIOCON PHARMA | 2026-04-28 | 4 |
| ANDA 208815 | ACTAVIS LABS FL | 2026-06-17 | 1 |
| ANDA 209938 | TEVA PHARMS USA | 2026-07-13 | 3 |
Official labeling on DailyMed
- ELTROMBOPAG TABLET, FILM COATED ELTROMBOPAG (ELTROMBOPAG OLAMINE) TABLET, FILM COATED [BIOCON PHARMA INC.] · version 2 · 2026-09-10
- ALVAIZ (ELTROMBOPAG) TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.] · version 8 · 2026-08-20
- ELTROMBOPAG OLAMINE TABLET, FILM COATED [AMERISYN, LLC] · version 2 · 2026-07-15
- ELTROMBOPAG (ELTROMBOPAG) TABLET, FILM COATED [XLCARE PHARMACEUTICALS INC.] · version 2 · 2026-07-06
- ELTROMBOPAG (ELTROMBOPAG) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] · version 4 · 2026-06-23
- ELTROMBOPAG OLAMINE (ELTROMBOPAG) TABLET, FILM COATED [AVKARE] · version 2 · 2026-05-22
- ELTROMBOPAG TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC.,] · version 6 · 2026-03-19
- ELTROMBOPAG TABLET [ZYDUS PHARMACEUTICALS USA INC.] · version 2 · 2026-01-23
- ELTROMBOPAG OLAMINE (ELTROMBOPAG) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC] · version 13 · 2026-01-21
- ELTROMBOPAG (ELTROMBOPAG OLAMINE) TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC] · version 1 · 2026-01-19
- ELTROMBOPAG TABLET [ZYDUS LIFESCIENCES LIMITED] · version 1 · 2026-01-16
- ELTROMBOPAG OLAMINE (ELTROMBOPAG) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC] · version 4 · 2026-01-16
Showing the 12 most recent of 15 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.