FDA.reportPublic FDA data

Application 021172

Type
BLA
Sponsor
NOVO NORDISK INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021172Novolog Mix 70/30insulin aspart protamine and insulin aspart351(a)Rx2026-09-01

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

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NovoLog Mix 70/30INSULIN ASPARTREMEDYREPACK INC.66da64f7-ca50-47d2-95fa-de37005eef852026-05-18Warnings, Adverse reactionsExact identifier
application number: BLA021172
ndc (product): 70518-2119
Insulin Aspart Protamine and Insulin Aspart Mix 70/30INSULIN ASPARTREMEDYREPACK INC.5d9f0e10-edb9-4960-bd62-cf406e75bbe72026-04-07Warnings, Adverse reactionsExact identifier
application number: BLA021172
ndc (product): 70518-3236
NovoLog Mix 70/30INSULIN ASPARTA-S Medication Solutions19888a44-b330-462a-864d-338c5893dd632026-01-29Warnings, Adverse reactionsExact identifier
application number: BLA021172
ndc (product): 50090-2272
ndc (product): 50090-2273
.Insulin Aspart Protamine and Insulin AspartINSULIN ASPARTA-S Medication Solutions14499781-b90e-47d5-a7de-006965439b942024-02-22Warnings, Adverse reactionsExact identifier
application number: BLA021172
ndc (product): 50090-4959
Insulin Aspart Protamine and Insulin Aspart Mix 70/30INSULIN ASPARTNovo Nordisk Pharma, Inc.fc94baa4-3606-48bc-a781-9617ab6960ef2023-02-28Warnings, Adverse reactionsExact identifier
application number: BLA021172
ndc (product): 73070-203
ndc (product): 73070-200

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 44 matching rows.

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 NordiskBLACurrent
0169-3685NovoLog Mix 70/30insulin aspartNovo NordiskNDACurrent
0169-3685NovoLog Mix 70/30insulin aspartNovo NordiskBLACurrent
0169-3685NovoLog Mix 70/30insulin aspartNovo NordiskNDACurrent
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 NordiskBLACurrent
0169-3696NovoLog Mix 70/30insulin aspartNovo NordiskNDACurrent
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.NDA AUTHORIZED GENERICCurrent
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.BLACurrent
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.NDA AUTHORIZED GENERICCurrent
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.BLACurrent
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