glucarpidase Injectable Solution

Brand(s)
Voraxaze
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Btg International Inc. (2013-03-12)
Oldest Current Product
2012-04-01
License(s)
BLA
RxNORM
INJECTABLE SOLUTION\GLUCARPIDASE
SPL Active
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\GLUCARPIDASE
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\GLUCARPIDASE

product(s) by strength(s)

glucarpidase 1000 unt/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1506330210VoraxazeBLABtg International Inc.2012-04-01GLUCARPIDASEINTRAVENOUSINJECTION, POWDER, FOR SOLUTION125327acaef5a6-b740-40e3-8ffe-74a75c74745c

application(s)

#idtitleapprovedtradenamesfda division
1125327glucarpidase Application2012-01-17VoraxazeCDER

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1acaef5a6-b740-40e3-8ffe-74a75c74745c (view SPL)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: 2012prescriptionHuman PrescriptionBtg International Inc.2013-03-125506330210

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII