digoxin antibodies Fab fragments Injectable Solution

Brand(s)
DigiFab
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Btg International Inc. (2015-11-06)
Oldest Current Product
2001-08-31
License(s)
BLA
RxNORM
INJECTABLE SOLUTION\DIGOXIN ANTIBODIES FAB FRAGMENTS
SPL Active
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\OVINE DIGOXIN IMMUNE FAB
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\DIGOXIN

product(s) by strength(s)

digoxin antibodies fab fragments 10 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1506330120DigiFabBLABtg International Inc.2001-08-31OVINE DIGOXIN IMMUNE FABINTRAVENOUSINJECTION, POWDER, FOR SOLUTION103910c05ee6a5-c98b-45f4-83fd-40781639d653

application(s)

#idtitleapprovedtradenamesfda division
1103910Digoxin Immune Fab (Ovine) Application2001-08-31DigiFabCBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
16832767f-db6b-4eea-b88b-bdfc905749e1 (view SPL)DIGIFAB DIGOXIN IMMUNE FAB (OVINE)prescriptionHuman PrescriptionSavage Laboratories A Division Of Fougera Pharmaceuticals Inc.ANALYSIS, MANUFACTURE2009-11-191002810365
2c05ee6a5-c98b-45f4-83fd-40781639d653 (view SPL)These highlights do not include all the information needed to use DIGIFAB safely and effectively. See full prescribing information for DIGIFAB . DigiFab , Digoxin Immune Fab (Ovine) For Intravenous Injection Only Lyophilized Powder for Solution IInitial U.S. Approval: 2001prescriptionHuman PrescriptionBtg International Inc.api manufacture, manufacture2015-11-062506330120

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