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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

Mylan Pharmaceuticals Inc.

DUNS: 059295980

Effective Date

March 9, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Sunitinib(12.5 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

0378-6678

Application Number

ANDA201275

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 7, 2021

Ingredients

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

SunitinibActive

Code: LVX8N1UT73Class: ACTIMQuantity: 12.5 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

Sunitinib Malate

Product Details

NDC Product Code

0378-6681

Application Number

ANDA201275

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 7, 2021

Ingredients

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SunitinibActive

Code: LVX8N1UT73Class: ACTIMQuantity: 37.5 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

Sunitinib Malate

Product Details

NDC Product Code

0378-6679

Application Number

ANDA201275

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 7, 2021

Ingredients

SunitinibActive

Code: LVX8N1UT73Class: ACTIMQuantity: 25 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

Sunitinib Malate

Product Details

NDC Product Code

0378-6680

Application Number

ANDA201275

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 7, 2021

Ingredients

SunitinibActive

Code: LVX8N1UT73Class: ACTIMQuantity: 50 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

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