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01 2Alembic Pharmaceuticals Limited

02 10Pfizer Inc

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PharmaCompass

01

FNCE
Not Confirmed
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FNCE
Not Confirmed

BOSUTINIB MONOHYDRATE

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

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02

FNCE
Not Confirmed
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FNCE
Not Confirmed

BOSUTINIB MONOHYDRATE

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

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03

FNCE
Not Confirmed
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FNCE
Not Confirmed

BOSUTINIB MONOHYDRATE

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

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04

FNCE
Not Confirmed
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FNCE
Not Confirmed

BOSUTINIB MONOHYDRATE

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

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05

FNCE
Not Confirmed
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FNCE
Not Confirmed

BOSUTINIB MONOHYDRATE

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

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06

FNCE
Not Confirmed
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FNCE
Not Confirmed

BOSUTINIB MONOHYDRATE

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

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07

FNCE
Not Confirmed
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FNCE
Not Confirmed

BOSUTINIB MONOHYDRATE

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

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08

FNCE
Not Confirmed
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FNCE
Not Confirmed

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

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09

FNCE
Not Confirmed
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FNCE
Not Confirmed

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

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10

FNCE
Not Confirmed
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FNCE
Not Confirmed

Bosutinib Monohydrate

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

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11

FNCE
Not Confirmed
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FNCE
Not Confirmed

Bosutinib Monohydrate

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

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12

FNCE
Not Confirmed
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FNCE
Not Confirmed

Bosutinib Monohydrate

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

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