Home Applications 103770 Application 103770
Type BLA
Sponsor MEDIMMUNE Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103770 Synagis palivizumab 351(a) Disc 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SYNAGIS PALIVIZUMAB VIAL 100MG/VIAL No No 002 SYNAGIS PALIVIZUMAB VIAL 50MG/VIAL No No
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 60574-4113 Synagis palivizumab MedImmune, LLC BLA Current 60574-4114 Synagis palivizumab MedImmune, LLC BLA Current 66658-230 Synagis palivizumab Swedish Orphan Biovitrum AB (publ) BLA Current 66658-230 Synagis palivizumab Swedish Orphan Biovitrum AB (publ) BLA Current 66658-230 Synagis palivizumab Swedish Orphan Biovitrum AB (publ) BLA Current 66658-231 Synagis palivizumab Swedish Orphan Biovitrum AB (publ) BLA Current 66658-231 Synagis palivizumab Swedish Orphan Biovitrum AB (publ) BLA Current 66658-231 Synagis palivizumab Swedish Orphan Biovitrum AB (publ) BLA Current