FDA.reportPublic FDA data

Application 021017

Type
BLA
Sponsor
LILLY

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

NDC Listings For This Application#

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 CompanyNDACurrent
0002-7511HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7511HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7511HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7511HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-7511HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-7511HumalogInsulin 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 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 CompanyBLACurrent
0002-8797HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-8797HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-8797HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-8797HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-8797HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-8797HumalogInsulin lisproEli Lilly and CompanyNDACurrent
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