FDA.reportPublic FDA data

Application 205692

Type
BLA
Sponsor
ELI LILLY AND CO

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
205692Basaglarinsulin glargine351(a)Disc2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BASAGLARINSULIN GLARGINESOLUTION;SUBCUTANEOUS300 UNITS/3ML (100 UNITS/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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BASAGLAR KwikPenINSULIN GLARGINEEli Lilly and Company0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae2026-06-16Warnings, Adverse reactionsExact identifier
application number: BLA205692
ndc (product): 0002-7715
ndc (product): 0002-8214

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 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-7715BASAGLARInsulin glargineEli Lilly and CompanyNDACurrent
0002-7715BASAGLARInsulin glargineEli Lilly and CompanyBLACurrent
0002-7715BASAGLARInsulin glargineEli Lilly and CompanyBLACurrent
0002-7715BASAGLARInsulin glargineEli Lilly and CompanyBLACurrent
0002-7715BASAGLARInsulin glargineEli Lilly and CompanyNDACurrent
0002-7715BASAGLARInsulin glargineEli Lilly and CompanyBLACurrent
0002-7715BASAGLARInsulin glargineEli Lilly and CompanyNDACurrent
0002-7715BASAGLARInsulin glargineEli Lilly and CompanyBLACurrent
0002-8214BASAGLARInsulin glargineEli Lilly and CompanyBLACurrent
0002-8214BASAGLARInsulin glargineEli Lilly and CompanyBLACurrent
0002-8214BASAGLARInsulin glargineEli Lilly and CompanyBLACurrent
0002-8214BASAGLARInsulin glargineEli Lilly and CompanyNDACurrent
0002-8214BASAGLARInsulin glargineEli Lilly and CompanyBLACurrent
0002-8214BASAGLARInsulin glargineEli Lilly and CompanyNDACurrent
0002-8214BASAGLARInsulin glargineEli Lilly and CompanyBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68168SUPPL2021-07-23
68149SUPPL2021-07-22
66367APPL2020-03-23
60893SUPPL2020-03-23
60892SUPPL2020-03-23
60891SUPPL2020-03-23
60876SUPPL2020-03-23
60875SUPPL2020-03-23
60874SUPPL2020-03-23
55410SUPPL2020-03-23
55388SUPPL2020-03-23
44930ORIG2020-03-23
43499ORIG2020-03-23
32704SUPPL2020-03-23
32703ORIG2020-03-23
32702ORIG2020-03-23
19674SUPPL2020-03-23
19673SUPPL2020-03-23
19672ORIG2020-03-23
10491SUPPL2020-03-23
10490ORIG2020-03-23