Active ingredient
Bosutinib
11 finished FDA listings contain Bosutinib as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- BOSUTINIB, BOSUTINIB MONOHYDRATE
- Dosage forms
- Capsule, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 5
- Strengths listed
- 100 mg/1 · 400 mg/1 · 50 mg/1 · 500 mg/1
- Brand names in FDA listings
- Bosulif
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1307619
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 203341 | PF PRISM CV | 2012-09-04 | 4 |
| NDA 217729 | PF PRISM CV | 2023-09-26 | 2 |
| ANDA 209543 | ALEMBIC | 2025-05-23 | 4 |
| ANDA 209624 | MSN | 2026-06-12 | 1 |
Official labeling on DailyMed
- BOSUTINIB TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC.] · version 1 · 2026-06-19
- BOSULIF (BOSUTINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] · version 6 · 2026-05-29
- BOSUTINIB TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.] · version 20 · 2026-05-25
- BOSUTINIB TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] · version 2 · 2026-05-25
- BOSULIF (BOSUTINIB) TABLET, FILM COATED BOSULIF (BOSUTINIB) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC] · version 32 · 2026-03-12
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.