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Approved Drug Products containing Bosutinib Monohydrate listed in the FDA Orange Book. Original Data : FDA Website

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BOSUTINIB MONOHYDRATE

Brand Name : BOSULIF

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 100MG BASE

Approval Date : 2012-09-04

Application Number : 203341

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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BOSUTINIB MONOHYDRATE

Brand Name : BOSULIF

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 500MG BASE

Approval Date : 2012-09-04

Application Number : 203341

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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BOSUTINIB MONOHYDRATE

Brand Name : BOSULIF

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 400MG BASE

Approval Date : 2017-10-27

Application Number : 203341

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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BOSUTINIB MONOHYDRATE

Brand Name : BOSULIF

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 50MG BASE

Approval Date : 2023-09-26

Application Number : 217729

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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BOSUTINIB MONOHYDRATE

Brand Name : BOSULIF

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 100MG BASE

Approval Date : 2023-09-26

Application Number : 217729

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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