FDA.reportPublic FDA data

Application 021017

Type
BLA
Sponsor
LILLY

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021017Humalog Mix 75/25insulin lispro protamine and insulin lispro351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HUMALOG MIX 75/25INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANTINJECTABLE;INJECTION75 UNITS/ML;25 UNITS/MLNoNo
002HUMALOG MIX 75/25 KWIKPENINSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANTINJECTABLE;INJECTION75 UNITS/ML;25 UNITS/MLNoNo
003HUMALOG MIX 75/25 PENINSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANTINJECTABLE;INJECTION75 UNITS/ML;25 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPenINSULIN LISPROEli Lilly and Companye49f701d-c19f-4cb2-b63f-01a917b33abc2024-08-06Warnings, Adverse reactionsExact identifier
application number: BLA021017
ndc (product): 0002-8233
Humalog Mix75/25 KwikPenINSULIN LISPROEli Lilly and Companyc73da51a-1899-45ad-b6cf-9c52c36a25dd2024-08-06Warnings, Adverse reactionsExact identifier
application number: BLA021017
ndc (product): 0002-7511
ndc (product): 0002-8797

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-7511HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-7511HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7511HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-7511HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7511HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7511HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-7511HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7511HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-7511HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-8233Insulin Lispro Protamine and Insulin Lispro Injectable SuspensionInsulin lisproEli Lilly and CompanyBLACurrent
0002-8233Insulin Lispro Protamine and Insulin Lispro Injectable SuspensionInsulin lisproEli Lilly and CompanyBLACurrent
0002-8233Insulin Lispro Protamine and Insulin Lispro Injectable SuspensionInsulin lisproEli Lilly and CompanyBLACurrent
0002-8233Insulin Lispro Protamine and Insulin Lispro Injectable SuspensionInsulin lisproEli Lilly and CompanyNDA AUTHORIZED GENERICCurrent
0002-8797HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-8797HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-8797HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-8797HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-8797HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-8797HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-8797HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-8797HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-8797HumalogInsulin lisproEli Lilly and CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74877SUPPL 2023-07-24
74871SUPPL 2023-07-24
62333APPL2020-03-25
60945SUPPL2020-03-23
60944SUPPL2020-03-23
60882SUPPL2020-03-23
60881SUPPL2020-03-23
55755SUPPL2020-03-23
55754SUPPL2020-03-23
55629SUPPL2020-03-23
55628SUPPL2020-03-23
46790SUPPL2020-03-23
46764SUPPL2020-03-23
41880SUPPL2020-03-23
41879ORIG2020-03-23
35904SUPPL2020-03-23
35903SUPPL2020-03-23
35902SUPPL2020-03-23
35901SUPPL2020-03-23
35900ORIG2020-03-23
26505SUPPL2020-03-23
26504SUPPL2020-03-23
14186SUPPL2020-03-23
14185SUPPL2020-03-23
14184SUPPL2020-03-23
14183SUPPL2020-03-23
14182SUPPL2020-03-23
14181SUPPL2020-03-23
14180SUPPL2020-03-23
4070SUPPL2020-03-23
4069SUPPL2020-03-23
4068SUPPL2020-03-23
4067SUPPL2020-03-23
4066SUPPL2020-03-23
4065SUPPL2020-03-23
4064SUPPL2020-03-23
4063SUPPL2020-03-23
4062SUPPL2020-03-23
4061SUPPL2020-03-23
4060ORIG2020-03-23