Bosutinib Monohydrate

For chronic phase (CP) Philadelphia chromosome-positive chronic … leukemia (Ph+ CML). ANDA 209543, held by Alembic. Bosutinib Monohydrate.

As of Nov 15, 2026, ANDA 209543 (Bosutinib Monohydrate), held by Alembic, was first approved by FDA on May 23, 2025, with 0 approved supplements and 0 published complete response letters.

First approved: May 23, 2025
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Bosutinib tablets are indicated for the treatment of:

Adult patients with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
May 23, 2025	Original application	Approved	None posted

Products

2 strengths and forms


Bosutinib MonohydrateEQ 100MG BASE · tablet;oral	Bosutinib Monohydrate	Rx
Bosutinib MonohydrateEQ 500MG BASE · tablet;oral	Bosutinib Monohydrate	Rx

All 2 submissions, including labeling and manufacturing supplements


Jun 12, 2026	Supplement 1Manufacturing	Tentative approval	None posted
May 23, 2025	Original application	Approved	None posted

Identifiers

Application: ANDA 209543
Drugs@FDA: Overview at FDA
Company: Alembic, LLC

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