FDA.reportPublic FDA data

Application 761063

Type
BLA
Sponsor
ELI LILLY AND CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EMGALITYGALCANEZUMAB-GNLMINJECTABLE;INJECTION120MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-1436EMGALITYgalcanezumabEli Lilly and CompanyBLACurrent
0002-1436EMGALITYgalcanezumabEli Lilly and CompanyBLACurrent
0002-1436EMGALITYgalcanezumab-gnlmEli Lilly and CompanyBLACurrent
0002-1436EMGALITYgalcanezumabEli Lilly and CompanyBLACurrent
0002-1436EMGALITYgalcanezumabEli Lilly and CompanyBLACurrent
0002-1436EMGALITYgalcanezumab-gnlmEli Lilly and CompanyBLACurrent
0002-2377EMGALITYgalcanezumabEli Lilly and CompanyBLACurrent
0002-2377EMGALITYgalcanezumabEli Lilly and CompanyBLACurrent
0002-2377EMGALITYgalcanezumabEli Lilly and CompanyBLACurrent
0002-2377EMGALITYgalcanezumab-gnlmEli Lilly and CompanyBLACurrent
0002-2377EMGALITYgalcanezumabEli Lilly and CompanyBLACurrent
0002-2377EMGALITYgalcanezumab-gnlmEli Lilly and CompanyBLACurrent
0002-3115EMGALITYgalcanezumab-gnlmEli Lilly and CompanyBLACurrent
0002-3115EMGALITYgalcanezumabEli Lilly and CompanyBLACurrent
0002-3115EMGALITYgalcanezumab-gnlmEli Lilly and CompanyBLACurrent
0002-3115EMGALITYgalcanezumabEli Lilly and CompanyBLACurrent
0002-3115EMGALITYgalcanezumabEli Lilly and CompanyBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81719SUPPL 2025-03-25
81696SUPPL 2025-03-24
71149SUPPL2022-05-26
71148SUPPL2022-05-25
61186SUPPL2019-12-06
61171SUPPL2019-12-06
58974SUPPL2019-06-05
58971SUPPL2019-06-05
56323ORIG2018-11-07
55761ORIG2018-10-01
55641ORIG2018-09-28