FDA.reportPublic FDA data

Application 021018

Type
BLA
Sponsor
LILLY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HUMALOG MIX 50/50INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANTINJECTABLE;INJECTION50 UNITS/ML;50 UNITS/MLNoNo
002HUMALOG MIX 50/50 KWIKPENINSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANTINJECTABLE;INJECTION50 UNITS/ML;50 UNITS/MLNoNo
003HUMALOG MIX 50/50 PENINSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANTINJECTABLE;INJECTION50 UNITS/ML;50 UNITS/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-7512HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-7512HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-7512HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-7512HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7512HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7512HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7512HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-7512HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-8798HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-8798HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-8798HumalogInsulin lisproEli Lilly and CompanyBLACurrent
0002-8798HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-8798HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-8798HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-8798HumalogInsulin lisproEli Lilly and CompanyNDACurrent
0002-8798HumalogInsulin lisproEli Lilly and CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74878SUPPL 2023-07-24
74872SUPPL 2023-07-24
66379APPL2020-03-23
60947SUPPL2020-03-23
60946SUPPL2020-03-23
60880SUPPL2020-03-23
60879SUPPL2020-03-23
57667SUPPL2020-03-23
55757SUPPL2020-03-23
55756SUPPL2020-03-23
55627SUPPL2020-03-23
55626SUPPL2020-03-23
46789SUPPL2020-03-23
46763SUPPL2020-03-23
41881ORIG2020-03-23
35910SUPPL2020-03-23
35909SUPPL2020-03-23
35908SUPPL2020-03-23
35907SUPPL2020-03-23
35906SUPPL2020-03-23
35905SUPPL2020-03-23
26513SUPPL2020-03-23
26512SUPPL2020-03-23
26511SUPPL2020-03-23
26510SUPPL2020-03-23
26509SUPPL2020-03-23
26508SUPPL2020-03-23
26507SUPPL2020-03-23
26506ORIG2020-03-23
14189SUPPL2020-03-23
14188SUPPL2020-03-23
14187ORIG2020-03-23
4072SUPPL2020-03-23
4071SUPPL2020-03-23