FDA.reportPublic FDA data

Application 019991

Type
BLA
Sponsor
NOVO NORDISK INC

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0169-1837NovolinHuman InsulinNovo NordiskBLACurrent
0169-1837NovolinHuman InsulinNovo NordiskBLACurrent
0169-1837NovolinHuman InsulinNovo NordiskBLACurrent
0169-1837NovolinHuman InsulinNovo NordiskNDACurrent
0169-1837NovolinHuman InsulinNovo NordiskNDACurrent
0169-3007NovolinHuman InsulinNovo NordiskBLACurrent
0169-3007NovolinHuman InsulinNovo NordiskBLACurrent
0169-3007NovolinHuman InsulinNovo NordiskBLACurrent
0169-3007NovolinHuman InsulinNovo NordiskNDACurrent
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