palivizumab Injection

Brand(s)
Synagis
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Medimmune, Llc (2014-03-27)
Oldest Current Product
1998-06-19
License(s)
BLA
RxNORM
INJECTION\PALIVIZUMAB
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\PALIVIZUMAB
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\PALIVIZUMAB

product(s) by strength(s)

0.5 ml palivizumab 100 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1605744114SynagisBLAMedimmune, Llc1999-12-09PALIVIZUMABINTRAMUSCULARINJECTION, SOLUTION1037708e35c4c8-bf56-458f-a73c-8f5733829788

1 ml palivizumab 100 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1605744113SynagisBLAMedimmune, Llc1998-06-19PALIVIZUMABINTRAMUSCULARINJECTION, SOLUTION1037708e35c4c8-bf56-458f-a73c-8f5733829788

application(s)

#idtitleapprovedtradenamesfda division
1103770palivizumab Application1998-06-19SynagisCDER

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
18e35c4c8-bf56-458f-a73c-8f5733829788 (view SPL)These highlights do not include all the information needed to use SYNAGIS safely and effectively. See full prescribing information for SYNAGIS. SYNAGIS (palivizumab) injection , for intramuscular use Initial U.S. Approval: 1998prescriptionHuman PrescriptionMedimmune, Llc2014-03-2728605744113, 605744114

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