FDA.reportPublic FDA data

Application 761109

Type
BLA
Sponsor
ELI LILLY AND CO

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761109Lyumjevinsulin lispro-aabc351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LYUMJEVINSULIN LISPRO-AABCINJECTABLE;INJECTION100UNITS/ML(U-100)NoNo
002LYUMJEVINSULIN LISPRO-AABCINJECTABLE;INJECTION200UNITS/ML(U-200)NoNo

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LYUMJEVINSULIN LISPRO-AABCA-S Medication Solutions616daea1-0b79-4970-a141-6f99f2072f022026-04-13Warnings, Adverse reactionsExact identifier
application number: BLA761109
LYUMJEVINSULIN LISPRO-AABCEli Lilly and Companyc5a056e2-b568-4ca6-9ed8-79c010942d002025-12-30Warnings, Adverse reactionsExact identifier
application number: BLA761109
ndc (product): 0002-7728
ndc (product): 0002-8207
ndc (product): 0002-8235
ndc (product): 0002-7726
ndc (product): 0002-8351
ndc (product): 0002-8228

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-7726LYUMJEVInsulin lispro-aabcEli Lilly and CompanyBLACurrent
0002-7726LYUMJEVInsulin lispro-aabcEli Lilly and CompanyBLACurrent
0002-7726LYUMJEVInsulin lispro-aabcEli Lilly and CompanyBLACurrent
0002-7726LYUMJEVInsulin lispro-aabcEli Lilly and CompanyBLACurrent
0002-7728LYUMJEVInsulin lispro-aabcEli Lilly and CompanyBLACurrent
0002-7728LYUMJEVInsulin lispro-aabcEli Lilly and CompanyBLACurrent
0002-7728LYUMJEVInsulin lispro-aabcEli Lilly and CompanyBLACurrent
0002-7728LYUMJEVInsulin lispro-aabcEli Lilly and CompanyBLACurrent
0002-8207LYUMJEVInsulin lispro-aabcEli Lilly and CompanyBLACurrent
0002-8207LYUMJEVInsulin lispro-aabcEli Lilly and CompanyBLACurrent
0002-8207LYUMJEVInsulin lispro-aabcEli Lilly and CompanyBLACurrent
0002-8207LYUMJEVInsulin lispro-aabcEli Lilly and CompanyBLACurrent
0002-8228LYUMJEVInsulin lispro-aabcEli Lilly and CompanyBLACurrent
0002-8228LYUMJEVInsulin lispro-aabcEli Lilly and CompanyBLACurrent
0002-8228LYUMJEVInsulin lispro-aabcEli Lilly and CompanyBLACurrent
0002-8228LYUMJEVInsulin lispro-aabcEli Lilly and CompanyBLACurrent
0002-8235LYUMJEVInsulin lispro-aabcEli Lilly and CompanyBLACurrent
0002-8235LYUMJEVInsulin lispro-aabcEli Lilly and CompanyBLACurrent
0002-8235LYUMJEVInsulin lispro-aabcEli Lilly and CompanyBLACurrent
0002-8235LYUMJEVInsulin lispro-aabcEli Lilly and CompanyBLACurrent
0002-8351LYUMJEVInsulin lispro-aabcEli Lilly and CompanyBLACurrent
0002-8351LYUMJEVInsulin lispro-aabcEli Lilly and CompanyBLACurrent
0002-8351LYUMJEVInsulin lispro-aabcEli Lilly and CompanyBLACurrent
0002-8351LYUMJEVInsulin lispro-aabcEli Lilly and CompanyBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72394SUPPL2022-10-17
72344SUPPL2022-10-17
68391SUPPL2021-08-17
68376SUPPL2021-08-16
67534ORIG2021-05-18
66000ORIG2021-01-26
65976ORIG2021-01-25
63603ORIG2020-06-17
63571ORIG2020-06-15