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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

NorthStar RxLLC

DUNS: 830546433

Effective Date

February 15, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Sunitinib(12.5 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

NorthStar RxLLC

DUNS Number

830546433

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Sun pharmaceutical industries Ltd.

Labeler

NorthStar RxLLC

Registrant

NorthStar RxLLC

DUNS Number

650445203

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

16714-676

Application Number

ANDA213914

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 15, 2022

Ingredients

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

SunitinibActive

Code: LVX8N1UT73Class: ACTIMQuantity: 12.5 mg in 1 1

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

Sunitinib malate

Product Details

NDC Product Code

16714-677

Application Number

ANDA213914

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 15, 2022

Ingredients

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

SunitinibActive

Code: LVX8N1UT73Class: ACTIMQuantity: 25 mg in 1 1

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

Sunitinib malate

Product Details

NDC Product Code

16714-679

Application Number

ANDA213914

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 15, 2022

Ingredients

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

SunitinibActive

Code: LVX8N1UT73Class: ACTIMQuantity: 50 mg in 1 1

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

Sunitinib malate

Product Details

NDC Product Code

16714-678

Application Number

ANDA213914

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 15, 2022

Ingredients

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

SunitinibActive

Code: LVX8N1UT73Class: ACTIMQuantity: 37.5 mg in 1 1

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

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