Active ingredient
Sunitinib
40 finished FDA listings contain Sunitinib as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- SUNITINIB MALATE
- Dosage forms
- Capsule
- Routes
- Oral
- Manufacturers / labelers
- 10
- Strengths listed
- 12.5 mg/1 · 25 mg/1 · 37.5 mg/1 · 50 mg/1
- Brand names in FDA listings
- Sutent
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 357977
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 021938 | CPPI CV | 2006-01-26 | 4 |
| ANDA 213914 | SUN PHARM | 2021-08-16 | 8 |
| ANDA 213803 | TEVA PHARMS USA | 2021-11-30 | 8 |
| ANDA 201275 | MYLAN | 2021-12-06 | 4 |
| ANDA 215843 | DR REDDYS | 2022-04-11 | 4 |
| ANDA 218012 | FOSUN WANBANG | 2023-08-21 | 4 |
| ANDA 218615 | EUGIA PHARMA | 2024-03-14 | 4 |
| ANDA 214824 | MSN | 2025-02-14 | 4 |
Official labeling on DailyMed
- SUNITINIB MALATE CAPSULE [TEVA PHARMACEUTICALS USA, INC.] · version 5 · 2026-09-02
- SUNITINIB MALATE CAPSULE [NORTHSTAR RXLLC] · version 3 · 2026-07-09
- SUTENT (SUNITINIB MALATE) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC] · version 50 · 2026-02-23
- SUNITINIB MALATE CAPSULE [AVKARE] · version 2 · 2026-01-19
- SUNITINIB MALATE CAPSULE [NOVADOZ PHARMACEUTICALS LLC] · version 1 · 2025-05-30
- SUNITINIB MALATE CAPSULE [AUROBINDO PHARMA LIMITED] · version 2 · 2025-04-21
- SUNITINIB MALATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES INC.] · version 8 · 2024-12-30
- SUNITINIB MALATE CAPSULE [NOVUGEN PHARMA (USA) LLC.] · version 2 · 2024-09-12
- SUNITINIB MALATE CAPSULE [MYLAN PHARMACEUTICALS INC.] · version 3 · 2024-05-08
- SUNITINIB MALATE CAPSULE [DR.REDDYS LABORATORIES INC] · version 5 · 2022-12-30
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.