Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Pfizer Manufacturing Deutschland GmbH
Pfizer Laboratories Div Pfizer Inc
341970073
Pfizer Ireland Pharmaceuticals
Pfizer Laboratories Div Pfizer Inc
985052076
Products5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
BOSULIF
Product Details
NDC Product Code
0069-0135Application Number
NDA203341Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 29, 2023BosutinibActive
Code: 844ZJE6I55Class: ACTIMQuantity: 100 mg in 1 1
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JGClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POVIDONE K25Inactive
Code: K0KQV10C35Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
BOSULIF
Product Details
NDC Product Code
0069-0193Application Number
NDA203341Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 29, 2023BosutinibActive
Code: 844ZJE6I55Class: ACTIMQuantity: 400 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
POVIDONE K25Inactive
Code: K0KQV10C35Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JGClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
BOSULIF
Product Details
NDC Product Code
0069-0136Application Number
NDA203341Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 29, 2023CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
BosutinibActive
Code: 844ZJE6I55Class: ACTIMQuantity: 500 mg in 1 1
POVIDONE K25Inactive
Code: K0KQV10C35Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JGClass: IACT
BOSULIF
Product Details
NDC Product Code
0069-0504Application Number
NDA217729Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 29, 2023CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JGClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
BosutinibActive
Code: 844ZJE6I55Class: ACTIMQuantity: 50 mg in 1 1
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
POVIDONE K25Inactive
Code: K0KQV10C35Class: IACT
BOSULIF
Product Details
NDC Product Code
0069-1014Application Number
NDA217729Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 29, 2023CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POVIDONE K25Inactive
Code: K0KQV10C35Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
BosutinibActive
Code: 844ZJE6I55Class: ACTIMQuantity: 100 mg in 1 1
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JGClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT