alemtuzumab Injection

Brand(s)
Campath, Lemtrada
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genzyme Corporation (2014-11-13)
Oldest Current Product
2009-11-30
License(s)
BLA
RxNORM
INJECTION\ALEMTUZUMAB
SPL Active
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\ALEMTUZUMAB
INTRAVENOUS\INJECTION\ALEMTUZUMAB
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\ALEMTUZUMAB
INTRAVENOUS\INJECTION\ALEMTUZUMAB

product(s) by strength(s)

1.2 ml alemtuzumab 10 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1584680200LemtradaBLAGenzyme Corporation2014-11-18ALEMTUZUMABINTRAVENOUSINJECTION, SOLUTION, CONCENTRATE1039486236b0bc-82e9-4447-9a78-f57d94770269

1 ml alemtuzumab 30 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1584680357CampathBLAGenzyme Corporation2009-11-30ALEMTUZUMABINTRAVENOUSINJECTION1039484f5f7255-7abc-4328-bd1a-ceaf139ef3e0

application(s)

#idtitleapprovedtradenamesfda division
1103948alemtuzumab Application2001-05-07Campath, LemtradaCDER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
14f5f7255-7abc-4328-bd1a-ceaf139ef3e0 (view SPL)These highlights do not include all the information needed to use CAMPATH safely and effectively. See full prescribing information for CAMPATH. CAMPATH(alemtuzumab)Injection for intravenous useInitial U.S. Approval: 2001prescriptionHuman PrescriptionGenzyme CorporationANALYSIS, API MANUFACTURE, MANUFACTURE2014-10-176584680357
26236b0bc-82e9-4447-9a78-f57d94770269 (view SPL)These highlights do not include all the information needed to use LEMTRADA safely and effectively. See full prescribing information for LEMTRADA. LEMTRADA (alemtuzumab) injection, for intravenous use Initial U.S. Approval: 2001prescriptionHuman PrescriptionGenzyme CorporationANALYSIS, API MANUFACTURE, MANUFACTURE2014-11-131584680200

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