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 use Initial U.S. Approval: 2012
Approved
Approval ID
d5929f91-6496-4c0e-97e8-0bd524e15763
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 28, 2021
Manufacturers
FDA
U.S. Pharmaceuticals
DUNS: 829076905
Products 2
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 Code63539-193
Application NumberNDA203341
Product Classification
M
Marketing Category
C73594
G
Generic Name
Bosutinib
Product Specifications
Route of AdministrationORAL
Effective DateOctober 28, 2021
FDA Product Classification
INGREDIENTS (11)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
BOSUTINIB MONOHYDRATEActive
Quantity: 400 mg in 1 1
Code: 844ZJE6I55
Classification: ACTIM
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Bosutinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63539-117
Application NumberNDA203341
Product Classification
M
Marketing Category
C73594
G
Generic Name
Bosutinib
Product Specifications
Route of AdministrationORAL
Effective DateOctober 28, 2021
FDA Product Classification
INGREDIENTS (11)
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
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
BOSUTINIB MONOHYDRATEActive
Quantity: 100 mg in 1 1
Code: 844ZJE6I55
Classification: ACTIM
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT