FDA.reportPublic FDA data

Application 021536

Type
BLA
Sponsor
NOVO NORDISK INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021536Levemirinsulin detemir351(a)Disc2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVEMIRINSULIN DETEMIR RECOMBINANTINJECTABLE;SUBCUTANEOUS1000 UNITS/10ML (100 UNITS/ML)NoNo
002LEVEMIR FLEXPENINSULIN DETEMIR RECOMBINANTINJECTABLE;SUBCUTANEOUS300 UNITS/3ML (100 UNITS/ML)NoNo
003LEVEMIR INNOLETINSULIN DETEMIR RECOMBINANTINJECTABLE;SUBCUTANEOUS300 UNITS/3ML (100 UNITS/ML)NoNo
004LEVEMIR PENFILLINSULIN DETEMIR RECOMBINANTINJECTABLE;SUBCUTANEOUS300 UNITS/3ML (100 UNITS/ML)NoNo
005LEVEMIR FLEXTOUCHINSULIN DETEMIR 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevemirINSULIN DETEMIRA-S Medication Solutions82192527-99aa-4b53-8ce9-9173668d309c2024-10-09Warnings, Adverse reactionsExact identifier
application number: BLA021536
ndc (product): 50090-1475
ndc (product): 50090-1276
LevemirINSULIN DETEMIRNovo Nordiskd38d65c1-25bf-401d-9c7e-a2c3222da8af2022-12-08Warnings, Adverse reactionsExact identifier
application number: BLA021536
ndc (product): 0169-6438
ndc (product): 0169-3687
ndc (product): 0169-6432

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0169-3687Levemirinsulin detemirNovo NordiskBLACurrent
0169-3687Levemirinsulin detemirNovo NordiskBLACurrent
0169-3687Levemirinsulin detemirNovo NordiskNDACurrent
0169-3687Levemirinsulin detemirNovo NordiskBLACurrent
0169-3687Levemirinsulin detemirNovo NordiskNDACurrent
0169-3687Levemirinsulin detemirNovo NordiskNDACurrent
0169-3687Levemirinsulin detemirNovo NordiskBLACurrent
0169-3687Levemirinsulin detemirNovo NordiskBLACurrent
0169-6432Levemirinsulin detemirNovo NordiskBLACurrent
0169-6438Levemirinsulin detemirNovo NordiskBLACurrent
0169-6438Levemirinsulin detemirNovo NordiskBLACurrent
0169-6438Levemirinsulin detemirNovo NordiskNDACurrent
0169-6438Levemirinsulin detemirNovo NordiskBLACurrent
0169-6438Levemirinsulin detemirNovo NordiskNDACurrent
0169-6438Levemirinsulin detemirNovo NordiskNDACurrent
0169-6438Levemirinsulin detemirNovo NordiskBLACurrent
0169-6438Levemirinsulin detemirNovo NordiskBLACurrent
50090-1276Levemirinsulin detemirA-S Medication SolutionsNDACurrent
50090-1276Levemirinsulin detemirA-S Medication SolutionsBLACurrent
50090-1276Levemirinsulin detemirA-S Medication SolutionsNDACurrent
50090-1276Levemirinsulin detemirA-S Medication SolutionsBLACurrent
50090-1276Levemirinsulin detemirA-S Medication SolutionsBLACurrent
50090-1276Levemirinsulin detemirA-S Medication SolutionsBLACurrent
50090-1475Levemirinsulin detemirA-S Medication SolutionsNDACurrent
50090-1475Levemirinsulin detemirA-S Medication SolutionsBLACurrent
50090-1475Levemirinsulin detemirA-S Medication SolutionsNDACurrent
50090-1475Levemirinsulin detemirA-S Medication SolutionsBLACurrent
50090-1475Levemirinsulin detemirA-S Medication SolutionsBLACurrent
50090-4501Levemirinsulin detemirA-S Medication SolutionsBLACurrent
50090-4501Levemirinsulin detemirA-S Medication SolutionsBLACurrent
50090-4501Levemirinsulin detemirA-S Medication SolutionsNDACurrent
68258-8977Levemirinsulin detemirDispensing Solutions, Inc.NDACurrent
70518-1387Levemirinsulin detemirREMEDYREPACK INC.NDACurrent
70518-1462Levemirinsulin detemirREMEDYREPACK INC.NDACurrent
70518-1462Levemirinsulin detemirREMEDYREPACK INC.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72867SUPPL2022-12-12
72847SUPPL2022-12-09
72837SUPPL2022-12-09
71522SUPPL2022-07-06
71508SUPPL2022-07-05
62424APPL2020-04-01
61596SUPPL2020-03-23
61473SUPPL2020-03-23
60905SUPPL2020-03-23
60904SUPPL2020-03-23
60899SUPPL2020-03-23
60898SUPPL2020-03-23
57318SUPPL2020-03-23
57248SUPPL2020-03-23
57202SUPPL2020-03-23
57201SUPPL2020-03-23
37178SUPPL2020-03-23
37177SUPPL2020-03-23
37176SUPPL2020-03-23
28056SUPPL2020-03-23
28055SUPPL2020-03-23
28054SUPPL2020-03-23
28053SUPPL2020-03-23
28052SUPPL2020-03-23
28051SUPPL2020-03-23
28050SUPPL2020-03-23
28049SUPPL2020-03-23
21724SUPPL2020-03-23
21723SUPPL2020-03-23
21722ORIG2020-03-23
15722SUPPL2020-03-23
15721SUPPL2020-03-23
15720SUPPL2020-03-23
15719SUPPL2020-03-23
15718SUPPL2020-03-23
15717SUPPL2020-03-23
15716SUPPL2020-03-23
15715SUPPL2020-03-23
15714SUPPL2020-03-23
15713ORIG2020-03-23
5677SUPPL2020-03-23
5676SUPPL2020-03-23
5675SUPPL2020-03-23
5674SUPPL2020-03-23
5673SUPPL2020-03-23
5672SUPPL2020-03-23
5671SUPPL2020-03-23
5670SUPPL2020-03-23
5669ORIG2020-03-23