FDA.reportPublic FDA data

Application 021878

Type
BLA
Sponsor
NOVO NORDISK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVEMIRINSULIN DETEMIRINJECTABLE; INJECTION100 UNITS/MLNoNo

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 ยท 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 reactionsName fallback
brand name: Levemir
generic name: INSULIN DETEMIR
LevemirINSULIN DETEMIRNovo Nordiskd38d65c1-25bf-401d-9c7e-a2c3222da8af2022-12-08Warnings, Adverse reactionsName fallback
brand name: Levemir
generic name: INSULIN DETEMIR

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62425APPL2020-04-02
42336ORIG2020-03-23
28759ORIG2020-03-23
16506ORIG2020-03-23