Pegloticase Injectable Solution

Brand(s)
Krystexxa
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Crealta Pharmaceuticals Llc (2015-07-24)
Oldest Current Product
2010-09-14
License(s)
BLA
RxNORM
INJECTABLE SOLUTION\PEGLOTICASE
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\PEGLOTICASE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\PEGLOTICASE

product(s) by strength(s)

pegloticase 8 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1608090801KrystexxaBLACrealta Pharmaceuticals Llc2010-09-14PEGLOTICASEINTRAVENOUSINJECTION, SOLUTION1252939c0d9fbb-998c-4a62-9354-7330d64b144e

application(s)

#idtitleapprovedtradenamesfda division
1125293pegloticase Application2010-09-14KrystexxaCDER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
15f4574d1-401f-4647-83e5-28c0f4a122a7 (view SPL)These highlights do not include all the information needed to use KRYSTEXXA safely and effectively. See full prescribing information for KRYSTEXXA KRYSTEXXA (pegloticase) Injection, for intravenous infusion Initial U.S. Approval: 2010prescriptionHuman PrescriptionSavient Pharmaceuticals, Inc.api manufacture, manufacture2012-09-155543960801
29c0d9fbb-998c-4a62-9354-7330d64b144e (view SPL)These highlights do not include all the information needed to use KRYSTEXXA safely and effectively. See full prescribing information for KRYSTEXXA KRYSTEXXA (pegloticase injection ) , for intravenous infusion Initial U.S. Approval: 2010prescriptionHuman PrescriptionCrealta Pharmaceuticals LlcAPI MANUFACTURE, MANUFACTURE2015-07-2410608090801

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