FDA.reportPublic FDA data

Application 103770

Type
BLA
Sponsor
MEDIMMUNE

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103770Synagispalivizumab351(a)Disc2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SYNAGISPALIVIZUMABVIAL100MG/VIALNoNo
002SYNAGISPALIVIZUMABVIAL50MG/VIALNoNo

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SynagisPALIVIZUMABSwedish Orphan Biovitrum AB (publ)3a0096c7-8139-44cd-bba4-520ab05c2cb22026-01-21Warnings, Adverse reactionsExact identifier
application number: BLA103770
ndc (product): 66658-230
ndc (product): 66658-231

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60574-4113SynagispalivizumabMedImmune, LLCBLACurrent
60574-4114SynagispalivizumabMedImmune, LLCBLACurrent
66658-230SynagispalivizumabSwedish Orphan Biovitrum AB (publ)BLACurrent
66658-230SynagispalivizumabSwedish Orphan Biovitrum AB (publ)BLACurrent
66658-230SynagispalivizumabSwedish Orphan Biovitrum AB (publ)BLACurrent
66658-231SynagispalivizumabSwedish Orphan Biovitrum AB (publ)BLACurrent
66658-231SynagispalivizumabSwedish Orphan Biovitrum AB (publ)BLACurrent
66658-231SynagispalivizumabSwedish Orphan Biovitrum AB (publ)BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72750APPL2022-11-30
48408SUPPL2017-05-17
48384SUPPL2017-05-16
18629SUPPL2014-03-25
31637SUPPL2014-03-24
43280SUPPL2013-08-09
22744SUPPL2013-08-09
18628SUPPL2012-04-06
9434SUPPL2012-04-06
9433SUPPL2011-05-17
18627SUPPL2009-03-24
9432SUPPL2009-03-24
18626SUPPL2008-11-20
9431SUPPL2008-08-05
39690SUPPL2007-03-07
31636SUPPL2007-03-06
9430SUPPL2005-03-03
39689SUPPL2004-12-22
39688SUPPL2004-03-29
31635SUPPL2004-03-29
31634ORIG2004-03-29
22743ORIG2004-03-29