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FDA Approval

Atorvastatin Calcium

CompanyMylan Pharmaceuticals Inc. (DUNS: 059295980)

Effective Date

July 14, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Ezetimibe/Amlodipine Besylate/Atorvastatin Calcium Trihydrate(20 mg in 1 1)

Products (4)

Atorvastatin Calcium

NDC Product Code

0378-3951

Application Number

ANDA091226

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 9, 2020

Ingredients

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

SODIUM CARBONATEInactive

Code: 45P3261C7TClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

Xanthan gumInactive

Code: TTV12P4NEEClass: CNTM

Lecithin, soybeanInactive

Code: 1DI56QDM62Class: CNTM

ARGININEInactive

Code: 94ZLA3W45FClass: IACT

Ezetimibe/Amlodipine Besylate/Atorvastatin Calcium TrihydrateActive

Code: 48A5M73Z4QClass: ACTIMQuantity: 20 mg in 1 1

Polyethylene glycol 400Inactive

Code: 3WJQ0SDW1AClass: CNTM

Atorvastatin Calcium

NDC Product Code

0378-3953

Application Number

ANDA091226

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 9, 2020

Ingredients

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

SODIUM CARBONATEInactive

Code: 45P3261C7TClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

ARGININEInactive

Code: 94ZLA3W45FClass: IACT

Xanthan gumInactive

Code: TTV12P4NEEClass: CNTM

Lecithin, soybeanInactive

Code: 1DI56QDM62Class: CNTM

Ezetimibe/Amlodipine Besylate/Atorvastatin Calcium TrihydrateActive

Code: 48A5M73Z4QClass: ACTIMQuantity: 80 mg in 1 1

Polyethylene glycol 400Inactive

Code: 3WJQ0SDW1AClass: CNTM

Atorvastatin Calcium

NDC Product Code

0378-3952

Application Number

ANDA091226

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 9, 2020

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

SODIUM CARBONATEInactive

Code: 45P3261C7TClass: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Xanthan gumInactive

Code: TTV12P4NEEClass: CNTM

ARGININEInactive

Code: 94ZLA3W45FClass: IACT

Lecithin, soybeanInactive

Code: 1DI56QDM62Class: CNTM

Ezetimibe/Amlodipine Besylate/Atorvastatin Calcium TrihydrateActive

Code: 48A5M73Z4QClass: ACTIMQuantity: 40 mg in 1 1

Polyethylene glycol 400Inactive

Code: 3WJQ0SDW1AClass: CNTM

Atorvastatin Calcium

NDC Product Code

0378-3950

Application Number

ANDA091226

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 9, 2020

Ingredients

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SODIUM CARBONATEInactive

Code: 45P3261C7TClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

ARGININEInactive

Code: 94ZLA3W45FClass: IACT

Xanthan gumInactive

Code: TTV12P4NEEClass: CNTM

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990Class: IACT

Lecithin, soybeanInactive

Code: 1DI56QDM62Class: CNTM

Ezetimibe/Amlodipine Besylate/Atorvastatin Calcium TrihydrateActive

Code: 48A5M73Z4QClass: ACTIMQuantity: 10 mg in 1 1

Polyethylene glycol 400Inactive

Code: 3WJQ0SDW1AClass: CNTM

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