FDA.reportPublic FDA data

Application 018780

Type
BLA
Sponsor
LILLY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HUMULIN RINSULIN RECOMBINANT HUMANINJECTABLE;INJECTION100 UNITS/MLNoNo
002HUMULIN R KWIKPENINSULIN HUMANSOLUTION;SUBCUTANEOUS1500 UNITS/3ML (500 UNITS/ML)NoNo
004HUMULIN RINSULIN HUMANSOLUTION;SUBCUTANEOUS10000 UNITS/20ML (500 UNITS/ML)NoNo
005HUMULIN R PENINSULIN RECOMBINANT HUMANINJECTABLE;INJECTION100 UNITS/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-8215HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8215HumulinInsulin humanEli Lilly and CompanyNDACurrent
0002-8215HumulinInsulin humanEli Lilly and CompanyNDACurrent
0002-8215HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8215HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8501HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8501HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8501HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8501HumulinInsulin humanEli Lilly and CompanyNDACurrent
0002-8501HumulinInsulin humanEli Lilly and CompanyNDACurrent
0002-8501HumulinInsulin humanEli Lilly and CompanyNDACurrent
0002-8824HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8824HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8824HumulinInsulin humanEli Lilly and CompanyBLACurrent
0002-8824HumulinInsulin humanEli Lilly and CompanyNDACurrent
0002-8824HumulinInsulin humanEli Lilly and CompanyNDACurrent
0002-8824HumulinInsulin humanEli Lilly and CompanyNDACurrent
50090-0353HumulinInsulin humanA-S Medication SolutionsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71482SUPPL2022-06-30
71461SUPPL2022-06-28
64284SUPPL2020-08-17
66369APPL2020-03-23
60934SUPPL2020-03-23
60933SUPPL2020-03-23
60903SUPPL2020-03-23
60901SUPPL2020-03-23
59838SUPPL2020-03-23
59822SUPPL2020-03-23
56445SUPPL2020-03-23
56370SUPPL2020-03-23
54379SUPPL2020-03-23
54378SUPPL2020-03-23
54375SUPPL2020-03-23
54374SUPPL2020-03-23
47639SUPPL2020-03-23
33601SUPPL2020-03-23
33600SUPPL2020-03-23
33599SUPPL2020-03-23
33598SUPPL2020-03-23
33597SUPPL2020-03-23
33596SUPPL2020-03-23
20158SUPPL2020-03-23
16045SUPPL2020-03-23
16044SUPPL2020-03-23
16043SUPPL2020-03-23
16042SUPPL2020-03-23
16041SUPPL2020-03-23
16040SUPPL2020-03-23
16039SUPPL2020-03-23
11330SUPPL2020-03-23
11329SUPPL2020-03-23
11328SUPPL2020-03-23
11327SUPPL2020-03-23
11326SUPPL2020-03-23
11325SUPPL2020-03-23
11324SUPPL2020-03-23
11323SUPPL2020-03-23
1078SUPPL2020-03-23
1077SUPPL2020-03-23
1076SUPPL2020-03-23
1075SUPPL2020-03-23
1074SUPPL2020-03-23
1073SUPPL2020-03-23
1072SUPPL2020-03-23
1071SUPPL2020-03-23
1070SUPPL2020-03-23
1069SUPPL2020-03-23