BCG, Live, Connaught Strain Topical Suspension

Brand(s)
TheraCys
Category(s)
other
SPL Type(s)
Vaccine
Master SPL
Sanofi Pasteur Inc. (2013-09-30)
Oldest Current Product
2011-07-22
License(s)
BLA
RxNORM
TOPICAL SUSPENSION\BCG, LIVE, CONNAUGHT STRAIN
SPL Active
INTRAVESICAL\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\BACILLUS CALMETTE-GUERIN SUBSTRAIN CONNAUGHT LIVE ANTIGEN
SPL Moiety
INTRAVESICAL\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\BACILLUS CALMETTE-GUERIN SUBSTRAIN CONNAUGHT LIVE ANTIGEN

product(s) by strength(s)

bcg, live, connaught strain 27 mg/ml topical suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1492810880TheraCysBLASanofi Pasteur Inc.2011-07-22BACILLUS CALMETTE-GUERIN SUBSTRAIN CONNAUGHT LIVE ANTIGENINTRAVESICALINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION1039438e456333-5a25-4484-84bf-53ece67c000a

application(s)

#idtitleapprovedtradenamesfda division
1103943BCG Live Application1990-05-21TheraCysCBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
18e456333-5a25-4484-84bf-53ece67c000a (view SPL)These highlights do not include all the information needed to use TheraCys safely and effectively. See full prescribing information for Theracys. TheraCys, BCG Live (Intravesical) Initial U.S. Approval: 1990otherVaccineSanofi Pasteur Inc.MANUFACTURE2013-09-309492810880

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