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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

Mylan Pharmaceuticals Inc.

DUNS: 059295980

Effective Date

February 15, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Pitavastatin(4 mg in 1 1)

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

0378-5057

Application Number

ANDA206070

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 15, 2023

Ingredients

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

PitavastatinActive

Code: IYD54XEG3WClass: ACTIMQuantity: 4 mg in 1 1

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 2165RE0K14Class: IACT

MAGNESIUM OXIDEInactive

Code: 3A3U0GI71GClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Pitavastatin Calcium

Product Details

NDC Product Code

0378-5055

Application Number

ANDA206070

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 15, 2023

Ingredients

LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 2165RE0K14Class: IACT

PitavastatinActive

Code: IYD54XEG3WClass: ACTIMQuantity: 1 mg in 1 1

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

MAGNESIUM OXIDEInactive

Code: 3A3U0GI71GClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Pitavastatin Calcium

Product Details

NDC Product Code

0378-5056

Application Number

ANDA206070

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 15, 2023

Ingredients

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

PitavastatinActive

Code: IYD54XEG3WClass: ACTIMQuantity: 2 mg in 1 1

LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 2165RE0K14Class: IACT

MAGNESIUM OXIDEInactive

Code: 3A3U0GI71GClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

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