Active ingredient
Sorafenib
9 finished FDA listings contain Sorafenib as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- SORAFENIB, SORAFENIB TOSYLATE
- Dosage forms
- Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 8
- Strengths listed
- 200 mg/1
- Brand names in FDA listings
- Nexavar, Sorafenib Tosylate
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 495881
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 021923 | BAYER HLTHCARE | 2005-12-01 | 2 |
| ANDA 207012 | MYLAN | 2020-09-10 | 1 |
| ANDA 209567 | TEVA PHARMS USA INC | 2020-11-12 | 1 |
| ANDA 216073 | DR REDDYS | 2022-06-07 | 1 |
| ANDA 209050 | YABAO PHARM | 2022-11-09 | 3 |
| ANDA 217095 | TORRENT | 2023-04-12 | 1 |
Official labeling on DailyMed
- SORAFENIB TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 10 · 2026-08-28
- SORAFENIB TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.] · version 4 · 2026-08-20
- SORAFENIB TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, LLC] · version 19 · 2026-07-06
- SORAFENIB TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING] · version 10 · 2026-06-03
- SORAFENIB TABLET, FILM COATED [DR.REDDYS LABORATORIES INC] · version 7 · 2026-05-21
- SORAFENIB TOSYLATE (SORAFENIB) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] · version 6 · 2026-03-20
- SORAFENIB TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED] · version 5 · 2026-03-04
- NEXAVAR (SORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] · version 40 · 2024-11-18
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.