Reteplase Injectable Solution

Brand(s)
Retavase
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Ekr Therapeutics, Inc. (2010-01-05)
Oldest Current Product
1996-10-30
License(s)
BLA
RxNORM
INJECTABLE SOLUTION\RETEPLASE
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\RETEPLASE
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\RETEPLASE

product(s) by strength(s)

reteplase 1 unt/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1244770040RetavaseBLAEkr Therapeutics, Inc.1996-10-30RETEPLASEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION103786e9ae6656-977c-4105-8528-bee664aab27a

application(s)

#idtitleapprovedtradenamesfda division
1103786reteplase Application1996-10-30RetavaseCDER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1e9ae6656-977c-4105-8528-bee664aab27a (view SPL)Retavase Reteplase, recombinantprescriptionHuman PrescriptionEkr Therapeutics, Inc.MANUFACTURE2010-01-053244770040, 244770041

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