FDA.reportPublic FDA data

Application 019959

Type
BLA
Sponsor
NOVO NORDISK INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
019959Novolin Ninsulin isophane human351(a)OTC2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NOVOLIN NINSULIN SUSP ISOPHANE RECOMBINANT HUMANINJECTABLE;INJECTION100 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
Novolin NHUMAN INSULINNovo Nordisk82f1445c-b2c6-445a-82cf-ba8825fac7762022-11-23Warnings, Adverse reactionsExact identifier
application number: BLA019959
ndc (product): 0169-3004
ndc (product): 0169-1834

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 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0169-1834NovolinHuman InsulinNovo NordiskNDACurrent
0169-1834NovolinHuman InsulinNovo NordiskNDACurrent
0169-1834NovolinHuman InsulinNovo NordiskBLACurrent
0169-1834NovolinHuman InsulinNovo NordiskBLACurrent
0169-1834NovolinHuman InsulinNovo NordiskNDACurrent
0169-3004NovolinHuman InsulinNovo NordiskNDACurrent
0169-3004NovolinHuman InsulinNovo NordiskBLACurrent
0169-3004NovolinHuman InsulinNovo NordiskBLACurrent
0169-3004NovolinHuman InsulinNovo NordiskNDACurrent
50090-0498NovolinHuman InsulinA-S Medication SolutionsBLACurrent
50090-0498NovolinHuman InsulinA-S Medication SolutionsBLACurrent
50090-0498NovolinHuman InsulinA-S Medication SolutionsNDACurrent
64725-1834NovolinHuman InsulinTYA PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72725SUPPL2022-11-28
72696SUPPL2022-11-25
66374APPL2020-03-23
60937SUPPL2020-03-23
60929SUPPL2020-03-23
54432SUPPL2020-03-23
54431SUPPL2020-03-23
54421SUPPL2020-03-23
54420SUPPL2020-03-23
34153SUPPL2020-03-23
34152SUPPL2020-03-23
34151SUPPL2020-03-23
34150SUPPL2020-03-23
20432SUPPL2020-03-23
19897SUPPL2020-03-23
19896SUPPL2020-03-23
19895SUPPL2020-03-23
12105SUPPL2020-03-23
12104SUPPL2020-03-23
12103SUPPL2020-03-23
12102SUPPL2020-03-23
12101SUPPL2020-03-23
1863SUPPL2020-03-23
1862SUPPL2020-03-23
1861SUPPL2020-03-23
1860SUPPL2020-03-23
1859SUPPL2020-03-23
1858SUPPL2020-03-23
1857SUPPL2020-03-23
1856SUPPL2020-03-23