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Generated: December 16, 2017

DrugPatentWatch Database Preview

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:1
Applicant:1
Ingredient:1
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;IV (INFUSION) 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;IV (INFUSION) 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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength400 UNITS/VIAL
Approval Date:Feb 26, 2010TE:RLD:No
Regulatory Exclusivity Expiration:Nov 21, 2016
Regulatory Exclusivity Use:ADDITION OF INFORMATION ON LONG-TERM TREATMENT WITH VPRIV IN THE CLINICAL TRIALS SECTION OF THE PACKAGE INSERT

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;IV (INFUSION)Strength200 UNITS/VIAL
Approval Date:Feb 26, 2010TE:RLD:No
Regulatory Exclusivity Expiration:Nov 21, 2016
Regulatory Exclusivity Use:ADDITION OF INFORMATION ON LONG-TERM TREATMENT WITH VPRIV IN THE CLINICAL TRIALS SECTION OF THE PACKAGE INSERT


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