FDA.reportPublic FDA data

Application 019717

Type
BLA
Sponsor
LILLY

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
019717Humulin 70/30insulin isophane human and insulin human351(a)OTC2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HUMULIN 70/30INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMANINJECTABLE;INJECTION30 UNITS/ML;70 UNITS/MLNoNo
002HUMULIN 70/30 PENINSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMANINJECTABLE;INJECTION30 UNITS/ML;70 UNITS/MLNoNo

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Humulin 70/30INSULIN HUMANEli Lilly and Companye245e0c5-b2d6-418b-baa4-1c33242928852026-06-17Warnings, Adverse reactionsExact identifier
application number: BLA019717
ndc (product): 0002-8803
ndc (product): 0002-8715

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 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-8715HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8715HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8715HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8715HumulinInsulin humanEli Lilly and CompanyNDACurrent
0002-8715HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8715HumulinInsulin humanEli Lilly and CompanyNDACurrent
0002-8715HumulinInsulin humanEli Lilly and CompanyNDACurrent
0002-8803HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8803HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8803HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8803HumulinInsulin humanEli Lilly and CompanyNDACurrent
0002-8803HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8803HumulinInsulin humanEli Lilly and CompanyNDACurrent
0002-8803HumulinInsulin humanEli Lilly and CompanyNDACurrent
50090-0444HumulinInsulin humanA-S Medication SolutionsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71484SUPPL2022-06-30
71460SUPPL2022-06-28
66373APPL2020-03-23
60943SUPPL2020-03-23
60942SUPPL2020-03-23
60890SUPPL2020-03-23
60889SUPPL2020-03-23
59831SUPPL2020-03-23
59824SUPPL2020-03-23
56448SUPPL2020-03-23
56379SUPPL2020-03-23
46787SUPPL2020-03-23
46733SUPPL2020-03-23
33887SUPPL2020-03-23
33886SUPPL2020-03-23
33885SUPPL2020-03-23
33884SUPPL2020-03-23
33883SUPPL2020-03-23
33882SUPPL2020-03-23
33881SUPPL2020-03-23
33880SUPPL2020-03-23
19119SUPPL2020-03-23
19118SUPPL2020-03-23
19117SUPPL2020-03-23
19116SUPPL2020-03-23
19115SUPPL2020-03-23
19114SUPPL2020-03-23
11651SUPPL2020-03-23
11650SUPPL2020-03-23
11649SUPPL2020-03-23
11648SUPPL2020-03-23
11647SUPPL2020-03-23
11646SUPPL2020-03-23
1539SUPPL2020-03-23
1538SUPPL2020-03-23
1537SUPPL2020-03-23
1536SUPPL2020-03-23
1535SUPPL2020-03-23
1534SUPPL2020-03-23
1533SUPPL2020-03-23
1532SUPPL2020-03-23
1531SUPPL2020-03-23
1530SUPPL2020-03-23
1529SUPPL2020-03-23
1528SUPPL2020-03-23
1527SUPPL2020-03-23
1526SUPPL2020-03-23