FDA.reportPublic FDA data

Application 020986

Type
BLA
Sponsor
NOVO NORDISK INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020986Novologinsulin aspart351(a)Rx2026-07-01

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

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Insulin AspartINSULIN ASPARTREMEDYREPACK INC.b3d77cb0-cd47-441f-8f54-5329c655da9c2026-01-14Warnings, Adverse reactionsExact identifier
application number: BLA020986
Insulin AspartINSULIN ASPARTA-S Medication Solutionsc3e4c46e-5211-4f05-b7ab-1e9ad270876b2024-09-11Warnings, Adverse reactionsExact identifier
application number: BLA020986
ndc (product): 50090-4956
Insulin AspartINSULIN ASPARTA-S Medication Solutionsbfd2b192-35e5-4773-ab73-802565b2ad782024-03-14Warnings, Adverse reactionsExact identifier
application number: BLA020986
ndc (product): 50090-4955
NOVOLOGINSULIN ASPARTA-S Medication Solutions13891e5a-e57a-46e8-911c-2f680352b52b2023-12-15Warnings, Adverse reactionsExact identifier
application number: BLA020986
ndc (product): 50090-4500
NOVOLOGINSULIN ASPARTA-S Medication Solutionse172b4f8-9b25-4019-8e09-afc10b2f30c92023-12-09Warnings, Adverse reactionsExact identifier
application number: BLA020986
ndc (product): 50090-1678
ndc (product): 50090-1664
ndc (product): 50090-1665
Insulin AspartINSULIN ASPARTNovo Nordisk Pharma, Inc.bee5b358-c863-420b-be73-ced2e920c4992023-02-28Warnings, Adverse reactionsExact identifier
application number: BLA020986
ndc (product): 73070-103
ndc (product): 73070-102
ndc (product): 73070-100
Insulin Diluting Medium for NovoLogWATER INJECTIONNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
application number: BLA020986
ndc (product): 0169-2100
ndc (product): 0169-2101
ndc (product): 0169-3303
ndc (product): 0169-7501
ndc (product): 0169-2001
ndc (product): 0169-6338
ndc (product): 0169-6339

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 72 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
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
0169-2001Insulin 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 NordiskNDACurrent
0169-3303NOVOLOGinsulin aspartNovo NordiskNDACurrent
0169-3303NOVOLOGinsulin aspartNovo NordiskNDACurrent
0169-3303NOVOLOGinsulin aspartNovo NordiskBLACurrent
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 NordiskNDACurrent
0169-6339NOVOLOGinsulin aspartNovo NordiskNDACurrent
0169-6339NOVOLOGinsulin aspartNovo NordiskNDACurrent
0169-6339NOVOLOGinsulin aspartNovo NordiskBLACurrent
0169-6339NOVOLOGinsulin aspartNovo NordiskBLACurrent
0169-6339NOVOLOGinsulin aspartNovo NordiskBLACurrent
0169-7501NOVOLOGinsulin aspartNovo NordiskNDACurrent
0169-7501NOVOLOGinsulin aspartNovo NordiskNDACurrent
0169-7501NOVOLOGinsulin aspartNovo NordiskNDACurrent
0169-7501NOVOLOGinsulin aspartNovo NordiskBLACurrent
0169-7501NOVOLOGinsulin aspartNovo NordiskBLACurrent
0169-7501NOVOLOGinsulin aspartNovo NordiskBLACurrent
50090-1664NOVOLOGinsulin aspartA-S Medication SolutionsBLACurrent
50090-1664NOVOLOGinsulin aspartA-S Medication SolutionsBLACurrent
50090-1664NOVOLOGinsulin aspartA-S Medication SolutionsBLACurrent
50090-1664NOVOLOGinsulin aspartA-S Medication SolutionsNDACurrent
50090-1664NOVOLOGinsulin aspartA-S Medication SolutionsBLACurrent
50090-1665NovoLoginsulin aspartA-S Medication SolutionsNDACurrent
50090-1678NOVOLOGinsulin aspartA-S Medication SolutionsBLACurrent
50090-1678NOVOLOGinsulin aspartA-S Medication SolutionsNDACurrent
50090-1678NOVOLOGinsulin aspartA-S Medication SolutionsBLACurrent
50090-1678NOVOLOGinsulin aspartA-S Medication SolutionsBLACurrent
50090-1678NOVOLOGinsulin aspartA-S Medication SolutionsNDACurrent
50090-1678NOVOLOGinsulin aspartA-S Medication SolutionsBLACurrent
50090-1678NOVOLOGinsulin aspartA-S Medication SolutionsBLACurrent
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.NDACurrent
70518-2252NOVOLOGinsulin aspartREMEDYREPACK INC.BLACurrent
70518-2252NOVOLOGinsulin aspartREMEDYREPACK INC.BLACurrent
70518-2252NOVOLOGinsulin aspartREMEDYREPACK INC.BLACurrent
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.NDA AUTHORIZED GENERICCurrent
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
73070-102Insulin 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
73070-103Insulin 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

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
60915SUPPL2020-03-23
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