← FDA DRUG APPROVALS

FDA NDA · NDA203341

BOSULIF

bosutinib

Sponsor: PF PRISM CV

APPLICATION
NDA203341
TYPE
NDA
ORIGINAL APPROVAL
2012-09-04
LATEST ACTION
2026-03-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BOSULIF · ReferencePrescription
BOSUTINIB MONOHYDRATE EQ 400MG BASE · TABLET · ORAL
BOSULIF · ReferencePrescription
BOSUTINIB MONOHYDRATE EQ 100MG BASE · TABLET · ORAL
BOSULIF · ReferencePrescription
BOSUTINIB MONOHYDRATE EQ 500MG BASE · TABLET · ORAL

Approval history

2026-03-02Labeling · Supplement 27 · standard — Letter ↗AP
2024-12-03Labeling · Supplement 26 · standard — Letter ↗AP
2023-09-26Efficacy · Supplement 25 · priority — Label ↗AP
2023-04-20Labeling · Supplement 24 · standard — Letter ↗AP
2021-05-14Efficacy · Supplement 20 · priority — Label ↗AP
2020-06-17Labeling · Supplement 18 · standard — Letter ↗AP
2019-10-09Labeling · Supplement 17 · standard — Letter ↗AP
2019-08-14Labeling · Supplement 16 · standard — Letter ↗AP
2018-10-18Labeling · Supplement 15 · standard — Label ↗AP
2018-05-01Labeling · Supplement 13 · standard — Letter ↗AP
2017-12-19Efficacy · Supplement 9 · priority — Label ↗AP
2017-04-13Efficacy · Supplement 7 · standard — Letter ↗AP
2017-04-13Labeling · Supplement 8 · standard — Letter ↗AP
2016-11-17Labeling · Supplement 6 · standard — Letter ↗AP
2016-04-04Labeling · Supplement 5 · standard — Label ↗AP
2015-10-08Labeling · Supplement 4 · standardAP
2015-09-22Labeling · Supplement 3 · standard — Letter ↗AP
2014-11-25Labeling · Supplement 2 — Label ↗AP
2013-09-30Labeling · Supplement 1 · standard — Label ↗AP
2012-09-04Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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