Quick answers
- What is Bosulif?
- Bosulif is a brand name of Bosutinib, a prescription medicine. The FDA NDC Directory lists 6 Bosulif products in 5 strengths and forms.
- Who makes Bosulif?
- PF Prism CV holds the FDA application for Bosulif (NDA203341, approved September 4, 2012). 1 other company (repackagers or distributors) also list Bosulif products.
- Is there a generic or store brand of Bosulif?
- Other products of Bosutinib are listed with the FDA, but none in exactly the same strength and form as a Bosulif product.
- Has Bosulif been recalled?
- No recall linked to Bosulif products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Bosulif is
Each Bosulif product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Bosutinib · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| bosutinib monohydrate 100 mg capsule (oral) | Bosulif | None listed | DailyMed |
| bosutinib monohydrate 100 mg tablet, film coated (oral) | Bosulif | None listed | DailyMed |
| bosutinib monohydrate 400 mg tablet, film coated (oral) | Bosulif | None listed | DailyMed |
| bosutinib monohydrate 50 mg capsule (oral) | Bosulif | None listed | DailyMed |
| bosutinib monohydrate 500 mg tablet, film coated (oral) | Bosulif | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Bosutinib →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Companies that list Bosulif
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Bosulif products.
- Pfizer Laboratories Div Pfizer Inc5 products
- U.S. Pharmaceuticals1 product
Recalls
No recall linked to Bosulif products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.