Treats chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant…. ANDA 209624, held by Msn. Bosutinib Monohydrate.
As of Nov 15, 2026, ANDA 209624 (Bosutinib Monohydrate, Bosutinib), held by Msn, was first approved by FDA on Jun 12, 2026, with 0 approved supplements and 0 published complete response letters.
Bosutinib tablets are indicated for the treatment of: Adult patients with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy. Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy. Pediatric use information is approved for PF PRISM CV’s BOSULIF (bosutinib) tablets. However, due to PF PRISM CV’s marketing exclusivity rights, this drug product is not labeled with that information.
| Jun 12, 2026 | Original application | Approved | |
| Jun 12, 2026 | Original application | Tentative approval | None posted |
| Bosutinib MonohydrateEQ 400MG BASE · tablet;oral | Bosutinib Monohydrate | Rx |
| BosutinibEQ 100MG BASE · tablet;film coated | Bosutinib Monohydrate | None (tentative approval) |
| BosutinibEQ 500MG BASE · tablet;film coated | Bosutinib Monohydrate | None (tentative approval) |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
