Home Applications 021018 Application 021018
Type BLA
Sponsor LILLY Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 021018 Humalog Mix 50/50 insulin lispro protamine and insulin lispro 351(a) Disc 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HUMALOG MIX 50/50 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT INJECTABLE;INJECTION 50 UNITS/ML;50 UNITS/ML No No 002 HUMALOG MIX 50/50 KWIKPEN INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT INJECTABLE;INJECTION 50 UNITS/ML;50 UNITS/ML No No 003 HUMALOG MIX 50/50 PEN INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT INJECTABLE;INJECTION 50 UNITS/ML;50 UNITS/ML No No
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0002-7512 Humalog Insulin lispro Eli Lilly and Company NDA Current 0002-7512 Humalog Insulin lispro Eli Lilly and Company NDA Current 0002-7512 Humalog Insulin lispro Eli Lilly and Company NDA Current 0002-7512 Humalog Insulin lispro Eli Lilly and Company NDA Current 0002-7512 Humalog Insulin lispro Eli Lilly and Company NDA Current 0002-7512 Humalog Insulin lispro Eli Lilly and Company BLA Current 0002-7512 Humalog Insulin lispro Eli Lilly and Company BLA Current 0002-7512 Humalog Insulin lispro Eli Lilly and Company BLA Current 0002-8798 Humalog Insulin lispro Eli Lilly and Company NDA Current 0002-8798 Humalog Insulin lispro Eli Lilly and Company NDA Current 0002-8798 Humalog Insulin lispro Eli Lilly and Company NDA Current 0002-8798 Humalog Insulin lispro Eli Lilly and Company NDA Current 0002-8798 Humalog Insulin lispro Eli Lilly and Company NDA Current 0002-8798 Humalog Insulin lispro Eli Lilly and Company BLA Current 0002-8798 Humalog Insulin lispro Eli Lilly and Company BLA Current 0002-8798 Humalog Insulin lispro Eli Lilly and Company BLA Current