Home Applications 019991 Application 019991
Type BLA
Sponsor NOVO NORDISK INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 019991 Novolin 70/30 insulin isophane human and insulin human 351(a) OTC 2026-09-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NOVOLIN 70/30 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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0169-1837 Novolin Human Insulin Novo Nordisk BLA Current 0169-1837 Novolin Human Insulin Novo Nordisk BLA Current 0169-1837 Novolin Human Insulin Novo Nordisk NDA Current 0169-1837 Novolin Human Insulin Novo Nordisk BLA Current 0169-1837 Novolin Human Insulin Novo Nordisk NDA Current 0169-3007 Novolin Human Insulin Novo Nordisk BLA Current 0169-3007 Novolin Human Insulin Novo Nordisk BLA Current 0169-3007 Novolin Human Insulin Novo Nordisk NDA Current 0169-3007 Novolin Human Insulin Novo Nordisk BLA Current 0169-3007 Novolin Human Insulin Novo Nordisk NDA Current 50090-0403 Novolin Human Insulin A-S Medication Solutions NDA Current 64725-1837 Novolin Human Insulin TYA Pharmaceuticals NDA Current