Voraxaze
These highlights do not include all the information needed to use VORAXAZE safely and effectively. See full prescribing information for VORAXAZE. VORAXAZE (glucarpidase) for injection, for intravenous use Initial U.S. Approval: 2012
Approved
Approval ID
acaef5a6-b740-40e3-8ffe-74a75c74745c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 18, 2022
Manufacturers
FDA
BTG International Inc.
DUNS: 617382395
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
glucarpidase
PRODUCT DETAILS
NDC Product Code50633-210
Application NumberBLA125327
Marketing CategoryC73585
Route of AdministrationINTRAVENOUS
Effective DateOctober 24, 2018
Generic Nameglucarpidase
INGREDIENTS (4)
GLUCARPIDASEActive
Quantity: 1000 [USP'U] in 1 1
Code: 2GFP9BJD79
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Quantity: 10 mg in 1 1
Code: EWQ57Q8I5X
Classification: IACT
ZINC ACETATEInactive
Quantity: 0.002 mg in 1 1
Code: FM5526K07A
Classification: IACT
TROMETHAMINE HYDROCHLORIDEInactive
Quantity: 0.6 mg in 1 1
Code: 383V75M34E
Classification: IACT