FDA.reportPublic FDA data

Application 205692

Type
BLA
Sponsor
ELI LILLY AND CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BASAGLARINSULIN GLARGINESOLUTION;SUBCUTANEOUS300 UNITS/3ML (100 UNITS/ML)NoNo

NDC Listings For This Application#

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

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