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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

Sun Pharmaceutical Industries Inc.

DUNS: 146974886

Effective Date

September 22, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Sunitinib(50 mg in 1 1)

Registrants1

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

Sun Pharmaceutical Industries Inc.

DUNS Number

146974886

Manufacturing Establishments1

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

Sun Pharmaceutical Industries Limited

Labeler

Sun Pharmaceutical Industries Inc.

Registrant

Sun Pharmaceutical Industries Inc.

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

63304-094

Application Number

ANDA213914

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 30, 2021

Ingredients

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

SunitinibActive

Code: LVX8N1UT73Class: ACTIMQuantity: 50 mg in 1 1

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

Sunitinib malate

Product Details

NDC Product Code

63304-092

Application Number

ANDA213914

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 30, 2021

Ingredients

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SunitinibActive

Code: LVX8N1UT73Class: ACTIMQuantity: 25 mg in 1 1

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

Sunitinib malate

Product Details

NDC Product Code

63304-093

Application Number

ANDA213914

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 30, 2021

Ingredients

SunitinibActive

Code: LVX8N1UT73Class: ACTIMQuantity: 37.5 mg in 1 1

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

Sunitinib malate

Product Details

NDC Product Code

63304-091

Application Number

ANDA213914

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 30, 2021

Ingredients

SunitinibActive

Code: LVX8N1UT73Class: ACTIMQuantity: 12.5 mg in 1 1

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

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