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FDA Approval

Sunitinib Malate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

DUNS: 796560394

Effective Date

October 11, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Sunitinib(25 mg in 1 1)

Products4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sunitinib Malate

Product Details

NDC Product Code

42291-902

Application Number

ANDA213803

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 11, 2023

Ingredients

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

SunitinibActive

Code: LVX8N1UT73Class: ACTIMQuantity: 25 mg in 1 1

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NHClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

FD&C BLUE NO. 2--ALUMINUM LAKEInactive

Code: 4AQJ3LG584Class: IACT

FD&C BLUE NO. 1 ALUMINUM LAKEInactive

Code: J9EQA3S2JMClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

Sunitinib Malate

Product Details

NDC Product Code

42291-903

Application Number

ANDA213803

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 11, 2023

Ingredients

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6Class: IACT

FD&C BLUE NO. 1 ALUMINUM LAKEInactive

Code: J9EQA3S2JMClass: IACT

FD&C BLUE NO. 2--ALUMINUM LAKEInactive

Code: 4AQJ3LG584Class: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

SunitinibActive

Code: LVX8N1UT73Class: ACTIMQuantity: 37.5 mg in 1 1

Sunitinib Malate

Product Details

NDC Product Code

42291-904

Application Number

ANDA213803

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 11, 2023

Ingredients

SunitinibActive

Code: LVX8N1UT73Class: ACTIMQuantity: 50 mg in 1 1

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FD&C BLUE NO. 1 ALUMINUM LAKEInactive

Code: J9EQA3S2JMClass: IACT

FD&C BLUE NO. 2--ALUMINUM LAKEInactive

Code: 4AQJ3LG584Class: IACT

Sunitinib Malate

Product Details

NDC Product Code

42291-901

Application Number

ANDA213803

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 11, 2023

Ingredients

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NHClass: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

D&C YELLOW NO. 10 ALUMINUM LAKEInactive

Code: CQ3XH3DET6Class: IACT

FD&C BLUE NO. 1 ALUMINUM LAKEInactive

Code: J9EQA3S2JMClass: IACT

FD&C BLUE NO. 2--ALUMINUM LAKEInactive

Code: 4AQJ3LG584Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

SunitinibActive

Code: LVX8N1UT73Class: ACTIMQuantity: 12.5 mg in 1 1

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