pembrolizumab Injection

Brand(s)
Keytruda
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Merck Sharp & Dohme Corp. (2015-10-02)
Oldest Current Product
2014-09-04
License(s)
BLA
RxNORM
INJECTION\PEMBROLIZUMAB
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\PEMBROLIZUMAB
INTRAVENOUS\INJECTION, SOLUTION\PEMBROLIZUMAB
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\PEMBROLIZUMAB
INTRAVENOUS\INJECTION, SOLUTION\PEMBROLIZUMAB

product(s) by strength(s)

4 ml pembrolizumab 25 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000063026KeytrudaBLAMerck Sharp & Dohme Corp.2015-01-15PEMBROLIZUMABINTRAVENOUSINJECTION, SOLUTION1255149333c79b-d487-4538-a9f0-71b91a02b287

pembrolizumab 50 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000063029KeytrudaBLAMerck Sharp & Dohme Corp.2014-09-04PEMBROLIZUMABINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION1255149333c79b-d487-4538-a9f0-71b91a02b287

application(s)

#idtitleapprovedtradenamesfda division
1125514pembrolizumab Application2014-09-04KeytrudaCDER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
19333c79b-d487-4538-a9f0-71b91a02b287 (view SPL)These highlights do not include all the information needed to use KEYTRUDA safely and effectively. See full prescribing information for KEYTRUDA. KEYTRUDA (pembrolizumab) for injection, for intravenous use KEYTRUDA (pembrolizumab) injection, for intravenous use Initial U.S. Approval: 2014prescriptionHuman PrescriptionMerck Sharp & Dohme Corp.API MANUFACTURE, MANUFACTURE, PACK2015-10-029000063026, 000063029

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