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Generated: December 18, 2018

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Details for New Drug Application (NDA): 022575

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NDA 022575 describes VPRIV, which is a drug marketed by Shire Human Genetic and is included in one NDA. It is available from one supplier. Additional details are available on the VPRIV profile page.

The generic ingredient in VPRIV is velaglucerase alfa. One supplier is listed for this compound. Additional details are available on the velaglucerase alfa profile page.
Summary for 022575
Tradename:VPRIV
Applicant:Shire Human Genetic
Ingredient:velaglucerase alfa
Patents:0
Pharmacology for NDA: 022575
Suppliers and Packaging for NDA: 022575
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VPRIV velaglucerase alfa INJECTABLE;INTRAVENOUS 022575 NDA Shire US Manufacturing Inc. 54092-701 54092-701-04 1 VIAL, GLASS in 1 BOX (54092-701-04) > 4 mL in 1 VIAL, GLASS
VPRIV velaglucerase alfa POWDER;INTRAVENOUS 022575 NDA Shire US Manufacturing Inc. 54092-701 54092-701-04 1 VIAL, GLASS in 1 BOX (54092-701-04) > 4 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength400 UNITS/VIAL
Approval Date:Feb 26, 2010TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;INTRAVENOUSStrength200 UNITS/VIAL
Approval Date:Feb 26, 2010TE:RLD:No

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