Sunitinib Malate

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

0772eb61-ca42-39de-e063-6294a90a6632

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 11, 2023

Manufacturers

FDA

AvKARE

DUNS: 796560394

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 Code42291-902

Application NumberANDA213803

Product Classification

Marketing Category

C73584

Generic Name

Sunitinib Malate

Product Specifications

Route of AdministrationORAL

Effective DateOctober 11, 2023

FDA Product Classification

INGREDIENTS (17)

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

SUNITINIB MALATEActive

Quantity: 25 mg in 1 1

Code: LVX8N1UT73

Classification: ACTIM

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

FD&C BLUE NO. 2--ALUMINUM LAKEInactive

Code: 4AQJ3LG584

Classification: IACT

FD&C BLUE NO. 1 ALUMINUM LAKEInactive

Code: J9EQA3S2JM

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

Sunitinib Malate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code42291-903

Application NumberANDA213803

Product Classification

Marketing Category

C73584

Generic Name

Sunitinib Malate

Product Specifications

Route of AdministrationORAL

Effective DateOctober 11, 2023

FDA Product Classification

INGREDIENTS (15)

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6

Classification: IACT

FD&C BLUE NO. 1 ALUMINUM LAKEInactive

Code: J9EQA3S2JM

Classification: IACT

FD&C BLUE NO. 2--ALUMINUM LAKEInactive

Code: 4AQJ3LG584

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

SUNITINIB MALATEActive

Quantity: 37.5 mg in 1 1

Code: LVX8N1UT73

Classification: ACTIM

Sunitinib Malate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code42291-904

Application NumberANDA213803

Product Classification

Marketing Category

C73584

Generic Name

Sunitinib Malate

Product Specifications

Route of AdministrationORAL

Effective DateOctober 11, 2023

FDA Product Classification

INGREDIENTS (16)

SUNITINIB MALATEActive

Quantity: 50 mg in 1 1

Code: LVX8N1UT73

Classification: ACTIM

SHELLACInactive

Code: 46N107B71O

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FD&C BLUE NO. 1 ALUMINUM LAKEInactive

Code: J9EQA3S2JM

Classification: IACT

FD&C BLUE NO. 2--ALUMINUM LAKEInactive

Code: 4AQJ3LG584

Classification: IACT

Sunitinib Malate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code42291-901

Application NumberANDA213803

Product Classification

Marketing Category

C73584

Generic Name

Sunitinib Malate

Product Specifications

Route of AdministrationORAL

Effective DateOctober 11, 2023

FDA Product Classification

INGREDIENTS (16)

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6

Classification: IACT

FD&C BLUE NO. 1 ALUMINUM LAKEInactive

Code: J9EQA3S2JM

Classification: IACT

FD&C BLUE NO. 2--ALUMINUM LAKEInactive

Code: 4AQJ3LG584

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

SUNITINIB MALATEActive

Quantity: 12.5 mg in 1 1

Code: LVX8N1UT73

Classification: ACTIM

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Sunitinib Malate

Products 4

Sunitinib Malate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

Sunitinib Malate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Sunitinib Malate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Sunitinib Malate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

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