FDA.reportPublic FDA data

Application 019938

Type
BLA
Sponsor
NOVO NORDISK INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
019938Novolin Rinsulin human351(a)OTC2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NOVOLIN RINSULIN 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 RHUMAN INSULINNovo Nordiskaee7f1f3-612c-4027-8ce9-4fd1f41eed712022-11-23Warnings, Adverse reactionsExact identifier
application number: BLA019938
ndc (product): 0169-1833
ndc (product): 0169-3003

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
0169-1833NovolinHuman InsulinNovo NordiskBLACurrent
0169-1833NovolinHuman InsulinNovo NordiskNDACurrent
0169-1833NovolinHuman InsulinNovo NordiskBLACurrent
0169-1833NovolinHuman InsulinNovo NordiskNDACurrent
0169-1833NovolinHuman InsulinNovo NordiskNDACurrent
0169-3003NovolinHuman InsulinNovo NordiskBLACurrent
0169-3003NovolinHuman InsulinNovo NordiskBLACurrent
0169-3003NovolinHuman InsulinNovo NordiskNDACurrent
0169-3003NovolinHuman InsulinNovo NordiskNDACurrent
50090-0497NovolinHuman InsulinA-S Medication SolutionsBLACurrent
50090-0497NovolinHuman InsulinA-S Medication SolutionsNDACurrent
64725-1833NovolinHuman InsulinTYA PharmaceuticalsNDACurrent
68071-1701NovolinHuman InsulinNuCare Pharmaceuticals,Inc.NDACurrent
68071-1701NovolinHuman InsulinNuCare Pharmaceuticals,Inc.NDACurrent
68071-1701NovolinHuman InsulinNuCare Pharmaceuticals,Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72724SUPPL2022-11-27
72695SUPPL2022-11-25
66371APPL2020-03-23
60935SUPPL2020-03-23
60930SUPPL2020-03-23
54433SUPPL2020-03-23
54419SUPPL2020-03-23
41098SUPPL2020-03-23
34108SUPPL2020-03-23
34107SUPPL2020-03-23
34106SUPPL2020-03-23
34105SUPPL2020-03-23
34104SUPPL2020-03-23
20426SUPPL2020-03-23
19855SUPPL2020-03-23
19854SUPPL2020-03-23
19853SUPPL2020-03-23
19852SUPPL2020-03-23
19851SUPPL2020-03-23
19850SUPPL2020-03-23
11861SUPPL2020-03-23
11860SUPPL2020-03-23
11859SUPPL2020-03-23
11858SUPPL2020-03-23
11857SUPPL2020-03-23
11856SUPPL2020-03-23
1824SUPPL2020-03-23
1823SUPPL2020-03-23
1822SUPPL2020-03-23
1821SUPPL2020-03-23
1820SUPPL2020-03-23
1819SUPPL2020-03-23
1818SUPPL2020-03-23