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FDA Approval

VPRIV

CompanyTakeda Pharmaceuticals America, Inc. (DUNS: 039997266)

Effective Date

October 24, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Velaglucerase alfa(2.5 mg in 1 mL)

Products (1)

VPRIV

NDC Product Code

54092-701

Application Number

BLA022575

Marketing Category

BLA (C73585)

Route of Administration

INTRAVENOUS

Effective Date

September 30, 2021

Ingredients

Velaglucerase alfaActive

Code: 23HYE36B0IClass: ACTIBQuantity: 2.5 mg in 1 mL

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACTQuantity: 1.26 mg in 1 mL

POLYSORBATE 20Inactive

Code: 7T1F30V5YHClass: IACTQuantity: 0.11 mg in 1 mL

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACTQuantity: 12.94 mg in 1 mL

SUCROSEInactive

Code: C151H8M554Class: IACTQuantity: 50 mg in 1 mL

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