alteplase Injectable Solution

Brand(s)
Activase, Cathflo Activase
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genentech, Inc. (2015-02-24)
Oldest Current Product
1987-11-13
License(s)
BLA
RxNORM
INJECTABLE SOLUTION\ALTEPLASE
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ALTEPLASE
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ALTEPLASE

product(s) by strength(s)

alteplase 1 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1502420041Cathflo ActivaseBLAGenentech, Inc.2001-09-04ALTEPLASEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION10317291ecdef2-95ff-42dd-a31c-c8a09cab3ad9
2502420044ActivaseBLAGenentech, Inc.1987-11-13ALTEPLASEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION103172c669f77c-fa48-478b-a14b-80b20a0139c2

application(s)

#idtitleapprovedtradenamesfda division
1103172alteplase, cathflo activase Application1987-11-13ActivaseCDER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
191ecdef2-95ff-42dd-a31c-c8a09cab3ad9 (view SPL)Cathflo Activase (Alteplase)prescriptionHuman PrescriptionGenentech, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2013-10-083502420041
2c669f77c-fa48-478b-a14b-80b20a0139c2 (view SPL)These highlights do not include all the information needed to use ACTIVASE safely and effectively. See full prescribing information for ACTIVASE. Activase (alteplase) for injection, for intravenous use Initial U.S. Approval: 1987prescriptionHuman PrescriptionGenentech, Inc.ANALYSIS, MANUFACTURE, PACK2015-02-243502420044, 502420085

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