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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

NORTHSTAR RX LLC

DUNS: 830546433

Effective Date

November 30, 2020

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Ezetimibe(10 mg in 1 1)

Simvastatin(40 mg in 1 1)

Manufacturing Establishments1

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

Glenmark Pharmaceuticals Limited

Labeler

NORTHSTAR RX LLC

DUNS Number

862603186

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

16714-780

Application Number

ANDA208699

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 30, 2020

Ingredients

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

lactose monohydrateInactive

Code: EWQ57Q8I5XClass: IACT

magnesium stearateInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

citric acid monohydrateInactive

Code: 2968PHW8QPClass: IACT

croscarmellose sodiumInactive

Code: M28OL1HH48Class: IACT

EzetimibeActive

Code: EOR26LQQ24Class: ACTIBQuantity: 10 mg in 1 1

SimvastatinActive

Code: AGG2FN16EVClass: ACTIBQuantity: 40 mg in 1 1

butylated hydroxyanisoleInactive

Code: REK4960K2UClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

propyl gallateInactive

Code: 8D4SNN7V92Class: IACT

ezetimibe and simvastatin

Product Details

NDC Product Code

16714-778

Application Number

ANDA208699

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 30, 2020

Ingredients

SimvastatinActive

Code: AGG2FN16EVClass: ACTIBQuantity: 10 mg in 1 1

EzetimibeActive

Code: EOR26LQQ24Class: ACTIBQuantity: 10 mg in 1 1

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

citric acid monohydrateInactive

Code: 2968PHW8QPClass: IACT

lactose monohydrateInactive

Code: EWQ57Q8I5XClass: IACT

magnesium stearateInactive

Code: 70097M6I30Class: IACT

butylated hydroxyanisoleInactive

Code: REK4960K2UClass: IACT

croscarmellose sodiumInactive

Code: M28OL1HH48Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

propyl gallateInactive

Code: 8D4SNN7V92Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

ezetimibe and simvastatin

Product Details

NDC Product Code

16714-781

Application Number

ANDA208699

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 30, 2020

Ingredients

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

magnesium stearateInactive

Code: 70097M6I30Class: IACT

EzetimibeActive

Code: EOR26LQQ24Class: ACTIBQuantity: 10 mg in 1 1

SimvastatinActive

Code: AGG2FN16EVClass: ACTIBQuantity: 80 mg in 1 1

butylated hydroxyanisoleInactive

Code: REK4960K2UClass: IACT

citric acid monohydrateInactive

Code: 2968PHW8QPClass: IACT

croscarmellose sodiumInactive

Code: M28OL1HH48Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

lactose monohydrateInactive

Code: EWQ57Q8I5XClass: IACT

propyl gallateInactive

Code: 8D4SNN7V92Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

ezetimibe and simvastatin

Product Details

NDC Product Code

16714-779

Application Number

ANDA208699

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 30, 2020

Ingredients

SimvastatinActive

Code: AGG2FN16EVClass: ACTIBQuantity: 20 mg in 1 1

EzetimibeActive

Code: EOR26LQQ24Class: ACTIBQuantity: 10 mg in 1 1

croscarmellose sodiumInactive

Code: M28OL1HH48Class: IACT

butylated hydroxyanisoleInactive

Code: REK4960K2UClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

lactose monohydrateInactive

Code: EWQ57Q8I5XClass: IACT

citric acid monohydrateInactive

Code: 2968PHW8QPClass: IACT

magnesium stearateInactive

Code: 70097M6I30Class: IACT

propyl gallateInactive

Code: 8D4SNN7V92Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

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