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FDA Approval

pitavastatin calcium

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

FDA Approval Summary

Company

Zydus Lifesciences Limited

DUNS: 918596198

Effective Date

November 3, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Pitavastatin(4 mg in 1 1)

Registrants1

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

Zydus Lifesciences Limited

DUNS Number

918596198

Manufacturing Establishments1

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

Zydus Lifesciences Limited

Labeler

Zydus Lifesciences Limited

Registrant

Zydus Lifesciences Limited

DUNS Number

918596198

Products3

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

pitavastatin calcium

Product Details

NDC Product Code

70771-1786

Application Number

ANDA206047

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 3, 2023

Ingredients

PitavastatinActive

Code: IYD54XEG3WClass: ACTIMQuantity: 4 mg in 1 1

CALCIUM CARBONATEInactive

Code: H0G9379FGKClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SODIUM CARBONATEInactive

Code: 45P3261C7TClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

pitavastatin calcium

Product Details

NDC Product Code

70771-1784

Application Number

ANDA206047

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 3, 2023

Ingredients

PitavastatinActive

Code: IYD54XEG3WClass: ACTIMQuantity: 1 mg in 1 1

CALCIUM CARBONATEInactive

Code: H0G9379FGKClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

SODIUM CARBONATEInactive

Code: 45P3261C7TClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

pitavastatin calcium

Product Details

NDC Product Code

70771-1785

Application Number

ANDA206047

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 3, 2023

Ingredients

PitavastatinActive

Code: IYD54XEG3WClass: ACTIMQuantity: 2 mg in 1 1

CALCIUM CARBONATEInactive

Code: H0G9379FGKClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

SODIUM CARBONATEInactive

Code: 45P3261C7TClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

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