Application 205747

Type
BLA
Sponsor
ELI LILLY AND CO

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
205747Humaloginsulin lispro351(a)Rx2026-07-01

Application Products#

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

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
Humalog KwikPenINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-01-09Warnings, Adverse reactionsExact identifier
application number: BLA205747
ndc (product): 0002-7712

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

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