ecallantide Injection

Brand(s)
Kalbitor
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Dyax Corp. (2015-03-01)
Oldest Current Product
2010-02-02
License(s)
BLA
RxNORM
INJECTION\ECALLANTIDE
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\ECALLANTIDE
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\ECALLANTIDE

product(s) by strength(s)

1 ml ecallantide 10 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1477830101KalbitorBLADyax Corp.2010-02-02ECALLANTIDESUBCUTANEOUSINJECTION, SOLUTION125277f56aec67-c662-477c-b866-bfc23e8809cf

application(s)

#idtitleapprovedtradenamesfda division
1125277ecallantide Application2009-12-01KalbitorCDER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1f56aec67-c662-477c-b866-bfc23e8809cf (view SPL)These highlights do not include all the information needed to use KALBITOR safely and effectively. See full prescribing information for KALBITOR. KALBITOR (ecallantide) injection for subcutaneous use Initial U.S. Approval: 2009prescriptionHuman PrescriptionDyax Corp.manufacture2015-03-0110477830101

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