azficel-T Injectable Suspension

Brand(s)
Laviv
Category(s)
other
SPL Type(s)
Cellular Therapy
Master SPL
Fibrocell Technologies, Inc. (2011-06-30)
Oldest Current Product
2011-07-15
License(s)
BLA
RxNORM
INJECTABLE SUSPENSION\AZFICEL-T
SPL Active
INTRADERMAL\INJECTION, SUSPENSION\AZFICEL-T
SPL Moiety
INTRADERMAL\INJECTION, SUSPENSION\AZFICEL-T

product(s) by strength(s)

azficel-t 15000000 cells/ml injectable suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1759350001LavivBLAFibrocell Technologies, Inc.2011-07-15AZFICEL-TINTRADERMALINJECTION, SUSPENSION1253484a41354f-c689-4216-82cc-bfc572f16374

application(s)

#idtitleapprovedfda division
1125348Azficel-TLaViv Application2011-06-21CBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
14a41354f-c689-4216-82cc-bfc572f16374 (view SPL)These highlights do not include all the information needed to use LAVIVTM (azficel-T) safely and effectively. See full prescribing information for LAVIV TM . LAVIV TM . (azficel-T) Suspension for Intradermal Injection. Initial U.S. Approval: 2011otherCellular TherapyFibrocell Technologies, Inc.analysis, api manufacture, label, manufacture, pack2011-06-301759350001

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