FDA.reportPublic FDA data

Application 205747

Type
BLA
Sponsor
ELI LILLY AND CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HUMALOG KWIKPENINSULIN LISPRO RECOMBINANTSOLUTION;SUBCUTANEOUS200 UNITS/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-7712HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-7712HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-7712HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-7712HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-7712HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7712HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7712HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7712HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7712HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7712HumalogInsulin lisproEli Lilly and CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82185SUPPL 2025-05-14
82259SUPPL 2025-05-07
74879SUPPL 2024-05-28
74873SUPPL 2023-07-24
66377APPL2020-03-23
60927SUPPL2020-03-23
60926SUPPL2020-03-23
60925SUPPL2020-03-23
60867SUPPL2020-03-23
60866SUPPL2020-03-23
60865SUPPL2020-03-23
59699SUPPL2020-03-23
59697SUPPL2020-03-23
56292SUPPL2020-03-23
56246SUPPL2020-03-23
48686SUPPL2020-03-23
48664SUPPL2020-03-23
46792SUPPL2020-03-23
46766SUPPL2020-03-23
46074ORIG2020-03-23
40499ORIG2020-03-23
10494ORIG2020-03-23