Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Pfizer Manufacturing Deutschland GmbH
U.S. Pharmaceuticals
341970073
Pfizer Ireland Pharmaceuticals
U.S. Pharmaceuticals
985052076
Products2
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
63539-193Application Number
NDA203341Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 28, 2021MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE K25Inactive
Code: K0KQV10C35Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JGClass: IACT
BosutinibActive
Code: 844ZJE6I55Class: ACTIMQuantity: 400 mg in 1 1
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
BOSULIF
Product Details
NDC Product Code
63539-117Application Number
NDA203341Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 28, 2021MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JGClass: IACT
BosutinibActive
Code: 844ZJE6I55Class: ACTIMQuantity: 100 mg in 1 1
POVIDONE K25Inactive
Code: K0KQV10C35Class: IACT