FDA.reportPublic FDA data

Application 761107

Type
BLA
Sponsor
NOVIMMUNE S.A.

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GAMIFANTEMAPALUMAB-LZSGINJECTABLE;INJECTION10MG/2MLNoNo
002GAMIFANTEMAPALUMAB-LZSGINJECTABLE;INJECTION50MG/10MLNoNo
003GAMIFANTEMAPALUMAB-LZSGINJECTABLE;INJECTION100MG/20MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66658-501GAMIFANT(emapalumab-lzsg)Swedish Orphan Biovitrum AB (publ)BLACurrent
66658-501GAMIFANT(emapalumab-lzsg)Swedish Orphan Biovitrum AB (publ)BLACurrent
66658-501GAMIFANT(emapalumab-lzsg)Swedish Orphan Biovitrum AB (publ)BLACurrent
66658-505GAMIFANT(emapalumab-lzsg)Swedish Orphan Biovitrum AB (publ)BLACurrent
66658-505GAMIFANT(emapalumab-lzsg)Swedish Orphan Biovitrum AB (publ)BLACurrent
66658-505GAMIFANT(emapalumab-lzsg)Swedish Orphan Biovitrum AB (publ)BLACurrent
66658-510GAMIFANT(emapalumab-lzsg)Swedish Orphan Biovitrum AB (publ)BLACurrent
66658-510GAMIFANT(emapalumab-lzsg)Swedish Orphan Biovitrum AB (publ)BLACurrent
72171-501GAMIFANT(emapalumab-lzsg)NovImmune SABLACurrent
72171-501GAMIFANT(emapalumab-lzsg)NovImmune SABLACurrent
72171-505GAMIFANT(emapalumab-lzsg)NovImmune SABLACurrent
72171-505GAMIFANT(emapalumab-lzsg)NovImmune SABLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85507SUPPL 2026-03-24
85474SUPPL 2026-03-24
85398SUPPL 2026-03-19
82714SUPPL 2025-06-30
82695SUPPL 2025-06-30
56754ORIG2018-12-17
56532ORIG2018-11-21
56516ORIG2018-11-20