Manufacturing Establishments3
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Pfizer Asia Manufacturing Pte Ltd
U.S. Pharmaceuticals
936889401
Pfizer Italia S.r.l.
U.S. Pharmaceuticals
458521908
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.
SUTENT
Product Details
NDC Product Code
63539-017Application Number
NDA021938Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
August 1, 2021MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SunitinibActive
Code: LVX8N1UT73Class: ACTIMQuantity: 12.5 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POVIDONE K25Inactive
Code: K0KQV10C35Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
SUTENT
Product Details
NDC Product Code
63539-019Application Number
NDA021938Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
August 1, 2021SunitinibActive
Code: LVX8N1UT73Class: ACTIMQuantity: 50 mg in 1 1
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POVIDONE K25Inactive
Code: K0KQV10C35Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT