FDA.reportPublic FDA data

Application 761215

Type
BLA
Sponsor
ELI LILLY CO

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761215Rezvoglarinsulin glargine-aglr351(k) InterchangeableRx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001REZVOGLARINSULIN GLARGINE-AGLRINJECTABLE;INJECTION3ML(100UNITS/ML)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
Rezvoglar KwikPenINSULIN GLARGINE-AGLREli Lilly and Companyf6af8706-2058-4fe1-99c8-43684c20bfa22024-08-09Warnings, Adverse reactionsExact identifier
application number: BLA761215
ndc (product): 0002-8980
REZVOGLAR KWIKPENINSULIN GLARGINE-AGLRA-S Medication Solutions78888c87-7155-4e81-954d-cb40822ee27b2023-05-02Warnings, Adverse reactionsExact identifier
application number: BLA761215

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-8980RezvoglarInsulin glargine-aglrEli Lilly and CompanyBLACurrent
0002-8980RezvoglarInsulin glargine-aglrEli Lilly and CompanyBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79376SUPPL 2024-08-12
79367SUPPL 2024-08-12
73009ORIG2022-12-22
72635ORIG2022-11-17
72622ORIG2022-11-16
69987ORIG2022-01-28
69724ORIG2021-12-21
69637ORIG2021-12-19