BOSULIF

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 useBOSULIF (bosutinib) capsules, for oral use Initial U.S. Approval: 2012

Approved

Approval ID

adc84ad5-a04d-4fee-9ba8-91f7abd928e3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 29, 2023

Manufacturers

FDA

Pfizer Laboratories Div Pfizer Inc

DUNS: 134489525

Products 5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Bosutinib

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0069-0135

Application NumberNDA203341

Product Classification

Marketing Category

C73594

Generic Name

Bosutinib

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 29, 2023

FDA Product Classification

INGREDIENTS (11)

BOSUTINIB MONOHYDRATEActive

Quantity: 100 mg in 1 1

Code: 844ZJE6I55

Classification: ACTIM

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

POLOXAMER 188Inactive

Code: LQA7B6G8JG

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

POVIDONE K25Inactive

Code: K0KQV10C35

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

Bosutinib

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0069-0193

Application NumberNDA203341

Product Classification

Marketing Category

C73594

Generic Name

Bosutinib

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 29, 2023

FDA Product Classification

INGREDIENTS (12)

BOSUTINIB MONOHYDRATEActive

Quantity: 400 mg in 1 1

Code: 844ZJE6I55

Classification: ACTIM

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

POVIDONE K25Inactive

Code: K0KQV10C35

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

POLOXAMER 188Inactive

Code: LQA7B6G8JG

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

Bosutinib

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0069-0136

Application NumberNDA203341

Product Classification

Marketing Category

C73594

Generic Name

Bosutinib

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 29, 2023

FDA Product Classification

INGREDIENTS (11)

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

BOSUTINIB MONOHYDRATEActive

Quantity: 500 mg in 1 1

Code: 844ZJE6I55

Classification: ACTIM

POVIDONE K25Inactive

Code: K0KQV10C35

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

POLOXAMER 188Inactive

Code: LQA7B6G8JG

Classification: IACT

Bosutinib

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0069-0504

Application NumberNDA217729

Product Classification

Marketing Category

C73594

Generic Name

Bosutinib

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 29, 2023

FDA Product Classification

INGREDIENTS (16)

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

POLOXAMER 188Inactive

Code: LQA7B6G8JG

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

BOSUTINIB MONOHYDRATEActive

Quantity: 50 mg in 1 1

Code: 844ZJE6I55

Classification: ACTIM

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

POVIDONE K25Inactive

Code: K0KQV10C35

Classification: IACT

Bosutinib

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0069-1014

Application NumberNDA217729

Product Classification

Marketing Category

C73594

Generic Name

Bosutinib

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 29, 2023

FDA Product Classification

INGREDIENTS (16)

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

POVIDONE K25Inactive

Code: K0KQV10C35

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

BOSUTINIB MONOHYDRATEActive

Quantity: 100 mg in 1 1

Code: 844ZJE6I55

Classification: ACTIM

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

POLOXAMER 188Inactive

Code: LQA7B6G8JG

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

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BOSULIF

Products 5

Bosutinib

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (11)

Bosutinib

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (12)

Bosutinib

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (11)

Bosutinib

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Bosutinib

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

MedPath

Product

Company

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