bosutinib Oral Tablet

Brand(s)
Bosulif
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pfizer Labs (2015-09-23)
Oldest Current Product
2012-09-04
License(s)
NDA
RxNORM
ORAL TABLET\BOSUTINIB
FDAOB
ORAL\TABLET\BOSUTINIB MONOHYDRATE
SPL Active
ORAL\TABLET, FILM COATED\BOSUTINIB MONOHYDRATE
SPL Moiety
ORAL\TABLET, FILM COATED\BOSUTINIB

product(s) by strength(s)

bosutinib 100 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1635390117BosulifNDAU.S. Pharmaceuticals2012-09-04BOSUTINIB MONOHYDRATEORALTABLET, FILM COATEDNDA203341d5929f91-6496-4c0e-97e8-0bd524e15763

bosutinib 500 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690136BosulifNDAPfizer Labs2012-09-04BOSUTINIB MONOHYDRATEORALTABLET, FILM COATEDNDA203341adc84ad5-a04d-4fee-9ba8-91f7abd928e3

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203341BOSULIFWYETH PHARMACEUTICALS INC2012-09-04pRE42376
p7767678, SUBSTANCE
p7919625, SUBSTANCE
p6002008, A METHOD OF TREATING A NEOPLASM, SUBSTANCE
p7417148, A METHOD OF TREATING CHRONIC MYELOGENOUS LEUKEMIA
NEW CHEMICAL ENTITY [2017-09-04]
ORPHAN DRUG EXCLUSIVITY [2019-09-04]
NDA203341_001, NDA203341_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203341_001RXBOSUTINIB MONOHYDRATE (EQ 100MG BASE)ORALTABLETTrue2012-09-04BOSULIF
2NDA203341_002RXBOSUTINIB MONOHYDRATE (EQ 500MG BASE)ORALTABLETFalse2012-09-04BOSULIF

patent(s)

#idexpiration dateapplication(s)
1p6002008 (view patent)2018-03-27NDA203341
2p7417148 (view patent)2026-01-23NDA203341
3p7767678 (view patent)2026-11-23NDA203341
4p7919625 (view patent)2025-12-11NDA203341
5pRE42376 (view patent)2019-09-24NDA203341

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1adc84ad5-a04d-4fee-9ba8-91f7abd928e3 (view SPL)These highlights do not include all the information needed to use BOSULIF safely and effectively. See full prescribing information for BOSULIF. BOSULIF (bosutinib) tablets, for oral use Initial U.S. Approval: 2012prescriptionHuman PrescriptionPfizer LabsANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-09-238000690136, 000690135
2d5929f91-6496-4c0e-97e8-0bd524e15763 (view SPL)These highlights do not include all the information needed to use BOSULIF safely and effectively. See full prescribing information for BOSULIF. BOSULIF (bosutinib) tablets, for oral use Initial U.S. Approval: 2012prescriptionHuman PrescriptionU.S. PharmaceuticalsAPI MANUFACTURE, MANUFACTURE, PACK2015-05-131635390117

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII