Home Applications 019717 Application 019717
Type BLA
Sponsor LILLY Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 019717 Humulin 70/30 insulin isophane human and insulin human 351(a) OTC 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HUMULIN 70/30 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN INJECTABLE;INJECTION 30 UNITS/ML;70 UNITS/ML No No 002 HUMULIN 70/30 PEN INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN INJECTABLE;INJECTION 30 UNITS/ML;70 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.
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NDC Listings For This Application# NDC listings for this application page 1 of 1 · 15 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0002-8715 Humulin Insulin human Eli Lilly and Company BLA Current 0002-8715 Humulin Insulin human Eli Lilly and Company BLA Current 0002-8715 Humulin Insulin human Eli Lilly and Company BLA Current 0002-8715 Humulin Insulin human Eli Lilly and Company NDA Current 0002-8715 Humulin Insulin human Eli Lilly and Company BLA Current 0002-8715 Humulin Insulin human Eli Lilly and Company NDA Current 0002-8715 Humulin Insulin human Eli Lilly and Company NDA Current 0002-8803 Humulin Insulin human Eli Lilly and Company BLA Current 0002-8803 Humulin Insulin human Eli Lilly and Company BLA Current 0002-8803 Humulin Insulin human Eli Lilly and Company BLA Current 0002-8803 Humulin Insulin human Eli Lilly and Company NDA Current 0002-8803 Humulin Insulin human Eli Lilly and Company BLA Current 0002-8803 Humulin Insulin human Eli Lilly and Company NDA Current 0002-8803 Humulin Insulin human Eli Lilly and Company NDA Current 50090-0444 Humulin Insulin human A-S Medication Solutions NDA Current