FDA.reportPublic FDA data

Application 021172

Type
BLA
Sponsor
NOVO NORDISK INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NOVOLOG MIX 70/30INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANTINJECTABLE;SUBCUTANEOUS700 UNITS/10ML; 300 UNITS/10ML (70 UNITS/ML; 30 UNITS/ML)NoNo
002NOVOLOG MIX 70/30 PENFILLINSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANTINJECTABLE;SUBCUTANEOUS210 UNITS/3ML;90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML)NoNo
003NOVOLOG MIX 70/30 PENFILLINSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANTINJECTABLE;SUBCUTANEOUS210 UNITS/3ML;90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML)NoNo
004NOVOLOG MIX 70/30 FLEXPENINSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANTINJECTABLE;SUBCUTANEOUS210 UNITS/3ML; 90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0169-2200NovoLog Mix 70/30insulin aspartNovo NordiskBLACurrent
0169-2201NovoLog Mix 70/30insulin aspartNovo NordiskBLACurrent
0169-3685NovoLog Mix 70/30insulin aspartNovo NordiskNDACurrent
0169-3685NovoLog Mix 70/30insulin aspartNovo NordiskNDACurrent
0169-3685NovoLog Mix 70/30insulin aspartNovo NordiskBLACurrent
0169-3685NovoLog Mix 70/30insulin aspartNovo NordiskBLACurrent
0169-3685NovoLog Mix 70/30insulin aspartNovo NordiskBLACurrent
0169-3696NovoLog Mix 70/30insulin aspartNovo NordiskBLACurrent
0169-3696NovoLog Mix 70/30insulin aspartNovo NordiskNDACurrent
0169-3696NovoLog Mix 70/30insulin aspartNovo NordiskNDACurrent
0169-3696NovoLog Mix 70/30insulin aspartNovo NordiskBLACurrent
0169-3696NovoLog Mix 70/30insulin aspartNovo NordiskBLACurrent
50090-2272NovoLog Mix 70/30insulin aspartA-S Medication SolutionsBLACurrent
50090-2272NovoLog Mix 70/30insulin aspartA-S Medication SolutionsBLACurrent
50090-2272NovoLog Mix 70/30insulin aspartA-S Medication SolutionsNDACurrent
50090-2272NovoLog Mix 70/30insulin aspartA-S Medication SolutionsNDACurrent
50090-2273NovoLog Mix 70/30insulin aspartA-S Medication SolutionsBLACurrent
50090-2273NovoLog Mix 70/30insulin aspartA-S Medication SolutionsNDACurrent
50090-4074NovoLog Mix 70/30insulin aspartA-S Medication SolutionsBLACurrent
50090-4074NovoLog Mix 70/30insulin aspartA-S Medication SolutionsBLACurrent
50090-4074NovoLog Mix 70/30insulin aspartA-S Medication SolutionsBLACurrent
50090-4074NovoLog Mix 70/30insulin aspartA-S Medication SolutionsBLACurrent
50090-4085NovoLog Mix 70/30insulin aspartA-S Medication SolutionsBLACurrent
50090-4085NovoLog Mix 70/30insulin aspartA-S Medication SolutionsBLACurrent
50090-4959.Insulin Aspart Protamine and Insulin Aspartinsulin aspartA-S Medication SolutionsBLACurrent
50090-4959.Insulin Aspart Protamine and Insulin Aspartinsulin aspartA-S Medication SolutionsBLACurrent
50090-4959.Insulin Aspart Protamine and Insulin Aspartinsulin aspartA-S Medication SolutionsBLACurrent
70518-2119NovoLog Mix 70/30insulin aspartREMEDYREPACK INC.NDACurrent
70518-2119NovoLog Mix 70/30insulin aspartREMEDYREPACK INC.BLACurrent
70518-2119NovoLog Mix 70/30insulin aspartREMEDYREPACK INC.BLACurrent
70518-2119NovoLog Mix 70/30insulin aspartREMEDYREPACK INC.BLACurrent
70518-3236Insulin Aspart Protamine and Insulin Aspartinsulin aspartREMEDYREPACK INC.BLACurrent
70518-3236Insulin Aspart Protamine and Insulin Aspartinsulin aspartREMEDYREPACK INC.BLACurrent
70518-3236Insulin Aspart Protamine and Insulin Aspartinsulin aspartREMEDYREPACK INC.BLACurrent
73070-200Insulin Aspart Protamine and Insulin Aspartinsulin aspartNovo Nordisk Pharma, Inc.BLACurrent
73070-200Insulin Aspart Protamine and Insulin Aspartinsulin aspartNovo Nordisk Pharma, Inc.BLACurrent
73070-200Insulin Aspart Protamine and Insulin Aspartinsulin aspartNovo Nordisk Pharma, Inc.NDA AUTHORIZED GENERICCurrent
73070-200Insulin Aspart Protamine and Insulin Aspartinsulin aspartNovo Nordisk Pharma, Inc.NDA AUTHORIZED GENERICCurrent
73070-200Insulin Aspart Protamine and Insulin Aspartinsulin aspartNovo Nordisk Pharma, Inc.NDA AUTHORIZED GENERICCurrent
73070-203.Insulin Aspart Protamine and Insulin Aspartinsulin aspartNovo Nordisk Pharma, Inc.BLACurrent
73070-203Insulin Aspart Protamine and Insulin Aspartinsulin aspartNovo Nordisk Pharma, Inc.BLACurrent
73070-203.Insulin Aspart Protamine and Insulin Aspartinsulin aspartNovo Nordisk Pharma, Inc.NDA AUTHORIZED GENERICCurrent
73070-203.Insulin Aspart Protamine and Insulin Aspartinsulin aspartNovo Nordisk Pharma, Inc.NDA AUTHORIZED GENERICCurrent
73070-203.Insulin Aspart Protamine and Insulin Aspartinsulin aspartNovo Nordisk Pharma, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73651SUPPL 2023-03-01
73641SUPPL 2023-03-01
67384SUPPL2021-05-04
67235SUPPL2021-04-29
62400APPL2020-03-31
60954SUPPL2020-03-23
60953SUPPL2020-03-23
60871SUPPL2020-03-23
60870SUPPL2020-03-23
56992SUPPL2020-03-23
56966SUPPL2020-03-23
48343SUPPL2020-03-23
48331SUPPL2020-03-23
36280SUPPL2020-03-23
36279SUPPL2020-03-23
36278SUPPL2020-03-23
36277SUPPL2020-03-23
36276SUPPL2020-03-23
36275SUPPL2020-03-23
36274SUPPL2020-03-23
36273SUPPL2020-03-23
36272ORIG2020-03-23
26987SUPPL2020-03-23
26986SUPPL2020-03-23
26985SUPPL2020-03-23
26984SUPPL2020-03-23
26983SUPPL2020-03-23
26982SUPPL2020-03-23
26981SUPPL2020-03-23
26980SUPPL2020-03-23
26979SUPPL2020-03-23
26978SUPPL2020-03-23
26977SUPPL2020-03-23
26976SUPPL2020-03-23
26975SUPPL2020-03-23
21488ORIG2020-03-23
14567SUPPL2020-03-23
14566SUPPL2020-03-23
14565SUPPL2020-03-23
14564SUPPL2020-03-23
14563SUPPL2020-03-23
14562SUPPL2020-03-23
4547SUPPL2020-03-23
4546SUPPL2020-03-23
4545SUPPL2020-03-23
4544SUPPL2020-03-23
4543SUPPL2020-03-23
4542ORIG2020-03-23