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FDA Approval

Ezetimibe and Simvastatin

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

FDA Approval Summary

Company

Amneal Pharmaceuticals NY LLC

DUNS: 123797875

Effective Date

January 28, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Ezetimibe(10 mg in 1 1)

Simvastatin(80 mg in 1 1)

Manufacturing Establishments1

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

Amneal Pharmaceuticals of New York, LLC

Labeler

Amneal Pharmaceuticals NY LLC

DUNS Number

123797875

Products4

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

Ezetimibe and Simvastatin

Product Details

NDC Product Code

60219-1158

Application Number

ANDA208831

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 28, 2022

Ingredients

EzetimibeActive

Code: EOR26LQQ24Class: ACTIBQuantity: 10 mg in 1 1

SimvastatinActive

Code: AGG2FN16EVClass: ACTIBQuantity: 80 mg in 1 1

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

PROPYL GALLATEInactive

Code: 8D4SNN7V92Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

Ezetimibe and Simvastatin

Product Details

NDC Product Code

60219-1156

Application Number

ANDA208831

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 28, 2022

Ingredients

EzetimibeActive

Code: EOR26LQQ24Class: ACTIBQuantity: 10 mg in 1 1

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

SimvastatinActive

Code: AGG2FN16EVClass: ACTIBQuantity: 20 mg in 1 1

PROPYL GALLATEInactive

Code: 8D4SNN7V92Class: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

Ezetimibe and Simvastatin

Product Details

NDC Product Code

60219-1155

Application Number

ANDA208831

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 28, 2022

Ingredients

EzetimibeActive

Code: EOR26LQQ24Class: ACTIBQuantity: 10 mg in 1 1

SimvastatinActive

Code: AGG2FN16EVClass: ACTIBQuantity: 10 mg in 1 1

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

PROPYL GALLATEInactive

Code: 8D4SNN7V92Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

Ezetimibe and Simvastatin

Product Details

NDC Product Code

60219-1157

Application Number

ANDA208831

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 28, 2022

Ingredients

EzetimibeActive

Code: EOR26LQQ24Class: ACTIBQuantity: 10 mg in 1 1

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

SimvastatinActive

Code: AGG2FN16EVClass: ACTIBQuantity: 40 mg in 1 1

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

PROPYL GALLATEInactive

Code: 8D4SNN7V92Class: IACT

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