Sunitinib malate
These highlights do not include all the information needed to use SUNITINIB MALATE CAPSULES safely and effectively. See full prescribing information for SUNITINIB MALATE CAPSULES.Initial U.S. Approval: 2006
Approved
Approval ID
7579e3d0-2de6-4239-a7a8-118ed92075f5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 15, 2022
Manufacturers
FDA
NorthStar RxLLC
DUNS: 830546433
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 Code16714-676
Application NumberANDA213914
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sunitinib malate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2022
FDA Product Classification
INGREDIENTS (10)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SUNITINIB MALATEActive
Quantity: 12.5 mg in 1 1
Code: LVX8N1UT73
Classification: ACTIM
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
Sunitinib malate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-677
Application NumberANDA213914
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sunitinib malate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2022
FDA Product Classification
INGREDIENTS (12)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SUNITINIB MALATEActive
Quantity: 25 mg in 1 1
Code: LVX8N1UT73
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
Sunitinib malate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-679
Application NumberANDA213914
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sunitinib malate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2022
FDA Product Classification
INGREDIENTS (12)
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SUNITINIB MALATEActive
Quantity: 50 mg in 1 1
Code: LVX8N1UT73
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Sunitinib malate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-678
Application NumberANDA213914
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sunitinib malate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2022
FDA Product Classification
INGREDIENTS (11)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SUNITINIB MALATEActive
Quantity: 37.5 mg in 1 1
Code: LVX8N1UT73
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT