FDA.reportPublic FDA data

Application 019959

Type
BLA
Sponsor
NOVO NORDISK INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NOVOLIN NINSULIN SUSP ISOPHANE RECOMBINANT HUMANINJECTABLE;INJECTION100 UNITS/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0169-1834NovolinHuman InsulinNovo NordiskBLACurrent
0169-1834NovolinHuman InsulinNovo NordiskBLACurrent
0169-1834NovolinHuman InsulinNovo NordiskNDACurrent
0169-1834NovolinHuman InsulinNovo NordiskNDACurrent
0169-1834NovolinHuman InsulinNovo NordiskNDACurrent
0169-3004NovolinHuman InsulinNovo NordiskBLACurrent
0169-3004NovolinHuman InsulinNovo NordiskBLACurrent
0169-3004NovolinHuman InsulinNovo NordiskNDACurrent
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