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01 2Alembic Pharmaceuticals Limited
02 10Pfizer Inc
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01 2CAPSULE;ORAL
02 3Film Coated Tablet
03 2TABLET
04 5TABLET;ORAL
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01 3Authorized
02 2Prescription
03 7RX
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01 7BOSULIF
02 2BOSUTINIB MONOHYDRATE
03 3Bosulif
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01 2Canada
02 3Spain
03 7USA
Regulatory Info : RX
Registration Country : USA
Brand Name : BOSUTINIB MONOHYDRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 100MG BASE
Packaging :
Approval Date : 2025-05-23
Application Number : 209543
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : BOSUTINIB MONOHYDRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 500MG BASE
Packaging :
Approval Date : 2025-05-23
Application Number : 209543
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : BOSULIF
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 100MG BASE
Packaging :
Approval Date : 2012-09-04
Application Number : 203341
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : BOSULIF
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 500MG BASE
Packaging :
Approval Date : 2012-09-04
Application Number : 203341
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : BOSULIF
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 400MG BASE
Packaging :
Approval Date : 2017-10-27
Application Number : 203341
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : BOSULIF
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 50MG BASE
Packaging :
Approval Date : 2023-09-26
Application Number : 217729
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : BOSULIF
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 100MG BASE
Packaging :
Approval Date : 2023-09-26
Application Number : 217729
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Prescription
Registration Country : Canada
BOSUTINIB (BOSUTINIB MONOHYDRATE)
Brand Name : BOSULIF
Dosage Form : TABLET
Dosage Strength : 100MG
Packaging : 28/120
Approval Date :
Application Number : 2419149
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
BOSUTINIB (BOSUTINIB MONOHYDRATE)
Brand Name : BOSULIF
Dosage Form : TABLET
Dosage Strength : 500MG
Packaging : 28/30
Approval Date :
Application Number : 2419157
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Bosulif
Dosage Form : Film Coated Tablet
Dosage Strength : 500MG
Packaging :
Approval Date : 2013-04-24
Application Number : 113818003
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Bosulif
Dosage Form : Film Coated Tablet
Dosage Strength : 400MG
Packaging :
Approval Date : 2018-06-05
Application Number : 113818006
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Bosulif
Dosage Form : Film Coated Tablet
Dosage Strength : 100MG
Packaging :
Approval Date : 2013-04-24
Application Number : 113818001
Regulatory Info : Authorized
Registration Country : Spain