autologous cultured chondrocytes Injectable Solution

Brand(s)
Carticel
Category(s)
other
SPL Type(s)
Cellular Therapy
Master SPL
Genzyme Corporation (2014-03-26)
Oldest Current Product
1997-08-22
License(s)
BLA
RxNORM
INJECTABLE SOLUTION\AUTOLOGOUS CULTURED CHONDROCYTES
SPL Active
INTRA-ARTICULAR\IMPLANT\AUTOLOGOUS CULTURED CHONDROCYTES
SPL Moiety
INTRA-ARTICULAR\IMPLANT\AUTOLOGOUS CULTURED CHONDROCYTES

product(s) by strength(s)

autologous cultured chondrocytes 30000000 cells/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1584681025CarticelBLAGenzyme Corporation1997-08-22AUTOLOGOUS CULTURED CHONDROCYTESINTRA-ARTICULARIMPLANT103661b13e343b-ff5f-4f1e-ae8f-0868148d58c6

application(s)

#idtitleapprovedfda division
1103661Autologous Cultured ChondrocytesCarticel SM Service Application1997-08-22CBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1b13e343b-ff5f-4f1e-ae8f-0868148d58c6 (view SPL)These highlights do not include all the information needed to use Carticel safely and effectively. See full prescribing information for Carticel. Carticel (autologous cultured chondrocytes)For Autologous ImplantationInitial U.S. Approval: 1997otherCellular TherapyGenzyme CorporationANALYSIS, MANUFACTURE2014-03-265584681025

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