FDA.reportPublic FDA data

Application 019991

Type
BLA
Sponsor
NOVO NORDISK INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
019991Novolin 70/30insulin isophane human and insulin human351(a)OTC2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NOVOLIN 70/30INSULIN 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Novolin 70/30HUMAN INSULINA-S Medication Solutionse825d7e9-467c-4f50-a6d6-f2602449c1de2023-02-06Warnings, Adverse reactionsExact identifier
application number: BLA019991
ndc (product): 50090-0403
Novolin 70/30HUMAN INSULINNovo Nordisk508a2763-3cb7-4be5-9e53-544e84cd9b1f2022-11-23Warnings, Adverse reactionsExact identifier
application number: BLA019991
ndc (product): 0169-1837
ndc (product): 0169-3007

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0169-1837NovolinHuman InsulinNovo NordiskBLACurrent
0169-1837NovolinHuman InsulinNovo NordiskBLACurrent
0169-1837NovolinHuman InsulinNovo NordiskNDACurrent
0169-1837NovolinHuman InsulinNovo NordiskBLACurrent
0169-1837NovolinHuman InsulinNovo NordiskNDACurrent
0169-3007NovolinHuman InsulinNovo NordiskBLACurrent
0169-3007NovolinHuman InsulinNovo NordiskBLACurrent
0169-3007NovolinHuman InsulinNovo NordiskNDACurrent
0169-3007NovolinHuman InsulinNovo NordiskBLACurrent
0169-3007NovolinHuman InsulinNovo NordiskNDACurrent
50090-0403NovolinHuman InsulinA-S Medication SolutionsNDACurrent
64725-1837NovolinHuman InsulinTYA PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72726SUPPL2022-11-28
72697SUPPL2022-11-25
60936SUPPL2020-03-23
60928SUPPL2020-03-23
54430SUPPL2020-03-23
54429SUPPL2020-03-23
54423SUPPL2020-03-23
54422SUPPL2020-03-23
41116SUPPL2020-03-23
34174SUPPL2020-03-23
34173SUPPL2020-03-23
34172SUPPL2020-03-23
19923SUPPL2020-03-23
19922SUPPL2020-03-23
19921SUPPL2020-03-23
19920SUPPL2020-03-23
12122SUPPL2020-03-23
12121SUPPL2020-03-23
12120SUPPL2020-03-23
12119SUPPL2020-03-23
12118SUPPL2020-03-23
12117SUPPL2020-03-23
1891SUPPL2020-03-23
1890SUPPL2020-03-23
1889SUPPL2020-03-23
1888SUPPL2020-03-23
1887SUPPL2020-03-23
1886SUPPL2020-03-23
66375APPL2020-03-22