FDA.reportPublic FDA data

Application 020986

Type
BLA
Sponsor
NOVO NORDISK INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NOVOLOGINSULIN ASPART RECOMBINANTINJECTABLE;SUBCUTANEOUS1000 UNITS/10ML (100 UNITS/ML)NoNo
002NOVOLOG PENFILLINSULIN ASPART RECOMBINANTINJECTABLE;SUBCUTANEOUS300 UNITS/3ML (100 UNITS/ML)NoNo
003NOVOLOG FLEXPENINSULIN ASPART RECOMBINANTINJECTABLE;SUBCUTANEOUS300 UNITS/3ML (100 UNITS/ML)NoNo
004NOVOLOG INNOLETINSULIN ASPART RECOMBINANTINJECTABLE;SUBCUTANEOUS300 UNITS/3ML (100 UNITS/ML)NoNo
005NOVOLOG FLEXTOUCHINSULIN ASPART RECOMBINANTINJECTABLE;SUBCUTANEOUS300 UNITS/3ML (100 UNITS/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0169-2001Insulin Diluting Medium for NovoLogwater injectionNovo NordiskBLACurrent
0169-2001Insulin Diluting Medium for NovoLogwater injectionNovo NordiskNDACurrent
0169-2001Insulin Diluting Medium for NovoLogwater injectionNovo NordiskNDACurrent
0169-2001Insulin Diluting Medium for NovoLogwater injectionNovo NordiskBLACurrent
0169-2001Insulin Diluting Medium for NovoLogwater injectionNovo NordiskBLACurrent
0169-2100NOVOLOGinsulin aspartNovo NordiskBLACurrent
0169-2100NOVOLOGinsulin aspartNovo NordiskBLACurrent
0169-2101NOVOLOGinsulin aspartNovo NordiskBLACurrent
0169-2101NOVOLOGinsulin aspartNovo NordiskBLACurrent
0169-3303NOVOLOGinsulin aspartNovo NordiskBLACurrent
0169-3303NOVOLOGinsulin aspartNovo NordiskNDACurrent
0169-3303NOVOLOGinsulin aspartNovo NordiskNDACurrent
0169-3303NOVOLOGinsulin aspartNovo NordiskNDACurrent
0169-3303NOVOLOGinsulin aspartNovo NordiskBLACurrent
0169-3303NOVOLOGinsulin aspartNovo NordiskBLACurrent
0169-6338NOVOLOGinsulin aspartNovo NordiskNDACurrent
0169-6338NOVOLOGinsulin aspartNovo NordiskNDACurrent
0169-6338NOVOLOGinsulin aspartNovo NordiskNDACurrent
0169-6338NOVOLOGinsulin aspartNovo NordiskBLACurrent
0169-6338NOVOLOGinsulin aspartNovo NordiskBLACurrent
0169-6338NOVOLOGinsulin aspartNovo NordiskBLACurrent
0169-6339NOVOLOGinsulin aspartNovo NordiskBLACurrent
0169-6339NOVOLOGinsulin aspartNovo NordiskNDACurrent
0169-6339NOVOLOGinsulin aspartNovo NordiskNDACurrent
0169-6339NOVOLOGinsulin aspartNovo NordiskNDACurrent
0169-6339NOVOLOGinsulin aspartNovo NordiskBLACurrent
0169-6339NOVOLOGinsulin aspartNovo NordiskBLACurrent
0169-7501NOVOLOGinsulin aspartNovo NordiskBLACurrent
0169-7501NOVOLOGinsulin aspartNovo NordiskBLACurrent
0169-7501NOVOLOGinsulin aspartNovo NordiskNDACurrent
0169-7501NOVOLOGinsulin aspartNovo NordiskNDACurrent
0169-7501NOVOLOGinsulin aspartNovo NordiskNDACurrent
0169-7501NOVOLOGinsulin aspartNovo NordiskBLACurrent
50090-1664NOVOLOGinsulin aspartA-S Medication SolutionsBLACurrent
50090-1664NOVOLOGinsulin aspartA-S Medication SolutionsNDACurrent
50090-1664NOVOLOGinsulin aspartA-S Medication SolutionsBLACurrent
50090-1664NOVOLOGinsulin aspartA-S Medication SolutionsBLACurrent
50090-1664NOVOLOGinsulin aspartA-S Medication SolutionsBLACurrent
50090-1665NovoLoginsulin aspartA-S Medication SolutionsNDACurrent
50090-1678NOVOLOGinsulin aspartA-S Medication SolutionsNDACurrent
50090-1678NOVOLOGinsulin aspartA-S Medication SolutionsBLACurrent
50090-1678NOVOLOGinsulin aspartA-S Medication SolutionsBLACurrent
50090-1678NOVOLOGinsulin aspartA-S Medication SolutionsBLACurrent
50090-1678NOVOLOGinsulin aspartA-S Medication SolutionsBLACurrent
50090-1678NOVOLOGinsulin aspartA-S Medication SolutionsBLACurrent
50090-1678NOVOLOGinsulin aspartA-S Medication SolutionsNDACurrent
50090-4500NOVOLOGinsulin aspartA-S Medication SolutionsBLACurrent
50090-4955Insulin Aspartinsulin aspartA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4955Insulin Aspartinsulin aspartA-S Medication SolutionsBLACurrent
50090-4956Insulin Aspartinsulin aspartA-S Medication SolutionsBLACurrent
50090-4956Insulin Aspartinsulin aspartA-S Medication SolutionsBLACurrent
64725-0750NovoLoginsulin aspartTYA PharmaceuticalsNDACurrent
68258-8899NovoLoginsulin aspartDispensing Solutions, Inc.NDACurrent
70518-2252NOVOLOGinsulin aspartREMEDYREPACK INC.BLACurrent
70518-2252NOVOLOGinsulin aspartREMEDYREPACK INC.BLACurrent
70518-2252NOVOLOGinsulin aspartREMEDYREPACK INC.BLACurrent
70518-2252NOVOLOGinsulin aspartREMEDYREPACK INC.NDACurrent
70518-2823Insulin Aspartinsulin aspartREMEDYREPACK INC.BLACurrent
70518-2823Insulin Aspartinsulin aspartREMEDYREPACK INC.BLACurrent
70518-2823Insulin Aspartinsulin aspartREMEDYREPACK INC.BLACurrent
73070-100Insulin Aspartinsulin aspartNovo Nordisk Pharma, Inc.BLACurrent
73070-100Insulin Aspartinsulin aspartNovo Nordisk Pharma, Inc.NDA AUTHORIZED GENERICCurrent
73070-100Insulin Aspartinsulin aspartNovo Nordisk Pharma, Inc.NDA AUTHORIZED GENERICCurrent
73070-100Insulin Aspartinsulin aspartNovo Nordisk Pharma, Inc.NDA AUTHORIZED GENERICCurrent
73070-102Insulin Aspartinsulin aspartNovo Nordisk Pharma, Inc.BLACurrent
73070-102Insulin Aspartinsulin aspartNovo Nordisk Pharma, Inc.NDA AUTHORIZED GENERICCurrent
73070-102Insulin Aspartinsulin aspartNovo Nordisk Pharma, Inc.NDA AUTHORIZED GENERICCurrent
73070-102Insulin Aspartinsulin aspartNovo Nordisk Pharma, Inc.NDA AUTHORIZED GENERICCurrent
73070-103Insulin Aspartinsulin aspartNovo Nordisk Pharma, Inc.BLACurrent
73070-103Insulin Aspartinsulin aspartNovo Nordisk Pharma, Inc.NDA AUTHORIZED GENERICCurrent
73070-103Insulin Aspartinsulin aspartNovo Nordisk Pharma, Inc.NDA AUTHORIZED GENERICCurrent
73070-103Insulin Aspartinsulin aspartNovo Nordisk Pharma, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73645SUPPL 2023-03-01
73640SUPPL 2023-03-01
72574SUPPL2022-11-07
72539SUPPL2022-11-02
68753SUPPL2021-09-24
68751SUPPL2021-09-24
66862SUPPL2021-03-24
66852SUPPL2021-03-24
62397APPL2020-03-31
66298SUPPL2020-03-23
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3936ORIG2020-03-23
63727ORIG1900-01-01
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