nivolumab Injection

Brand(s)
Opdivo
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
E.R. Squibb & Sons, L.L.C. (2015-10-09)
Oldest Current Product
2014-12-22
License(s)
BLA
RxNORM
INJECTION\NIVOLUMAB
SPL Active
INTRAVENOUS\INJECTION\NIVOLUMAB
SPL Moiety
INTRAVENOUS\INJECTION\NIVOLUMAB

product(s) by strength(s)

4 ml nivolumab 10 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000033772OpdivoBLAE.R. Squibb & Sons, L.L.C.2014-12-22NIVOLUMABINTRAVENOUSINJECTION125554f570b9c4-6846-4de2-abfa-4d0a4ae4e394

10 ml nivolumab 10 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000033774OpdivoBLAE.R. Squibb & Sons, L.L.C.2014-12-22NIVOLUMABINTRAVENOUSINJECTION125554f570b9c4-6846-4de2-abfa-4d0a4ae4e394

application(s)

#idtitleapprovedtradenamesfda division
1125554nivolumab Application2014-12-22OpdivoCDER

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1f570b9c4-6846-4de2-abfa-4d0a4ae4e394 (view SPL)These highlights do not include all the information needed to use OPDIVO safely and effectively. See full prescribing information for OPDIVO. OPDIVO (nivolumab) injection, for intravenous useInitial U.S. Approval: 2014prescriptionHuman PrescriptionE.R. Squibb & Sons, L.L.C.2015-10-093000033772, 000033774

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