Sunitinib Malate
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 2006
Approved
Approval ID
4dbfcc02-dacc-4f0c-9f41-095783b68e27
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 9, 2022
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sunitinib malate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-6678
Application NumberANDA201275
Product Classification
M
Marketing Category
C73584
G
Generic Name
sunitinib malate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 7, 2021
FDA Product Classification
INGREDIENTS (13)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SUNITINIB MALATEActive
Quantity: 12.5 mg in 1 1
Code: LVX8N1UT73
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
sunitinib malate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-6681
Application NumberANDA201275
Product Classification
M
Marketing Category
C73584
G
Generic Name
sunitinib malate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 7, 2021
FDA Product Classification
INGREDIENTS (13)
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SUNITINIB MALATEActive
Quantity: 37.5 mg in 1 1
Code: LVX8N1UT73
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
sunitinib malate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-6679
Application NumberANDA201275
Product Classification
M
Marketing Category
C73584
G
Generic Name
sunitinib malate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 7, 2021
FDA Product Classification
INGREDIENTS (14)
SUNITINIB MALATEActive
Quantity: 25 mg in 1 1
Code: LVX8N1UT73
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
sunitinib malate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-6680
Application NumberANDA201275
Product Classification
M
Marketing Category
C73584
G
Generic Name
sunitinib malate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 7, 2021
FDA Product Classification
INGREDIENTS (13)
SUNITINIB MALATEActive
Quantity: 50 mg in 1 1
Code: LVX8N1UT73
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT