Application 208751

Type
BLA
Sponsor
NOVO

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
208751Fiaspinsulin aspart351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FIASPINSULIN ASPARTSOLUTION;INTRAVENOUS, SUBCUTANEOUS1000 UNITS/10ML (100 UNITS/ML)NoNo
002FIASP FLEXTOUCHINSULIN ASPARTSOLUTION;SUBCUTANEOUS300 UNITS/3ML (100 UNITS/ML)NoNo
003FIASP PENFILLINSULIN ASPARTSOLUTION;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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FiaspINSULIN ASPART INJECTIONNovo Nordisk834e7efc-393f-4c55-9125-628562a8a5cf2023-06-21Warnings, Adverse reactionsExact identifier
application number: BLA208751
ndc (product): 0169-3204
ndc (product): 0169-3205
ndc (product): 0169-3201

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0169-3201Fiaspinsulin aspart injectionNovo NordiskBLACurrent
0169-3201Fiaspinsulin aspart injectionNovo NordiskNDACurrent
0169-3201Fiaspinsulin aspart injectionNovo NordiskNDACurrent
0169-3201Fiaspinsulin aspart injectionNovo NordiskNDACurrent
0169-3201Fiaspinsulin aspart injectionNovo NordiskNDACurrent
0169-3201Fiaspinsulin aspart injectionNovo NordiskNDACurrent
0169-3201Fiaspinsulin aspart injectionNovo NordiskBLACurrent
0169-3201Fiaspinsulin aspart injectionNovo NordiskBLACurrent
0169-3201Fiaspinsulin aspart injectionNovo NordiskNDACurrent
0169-3201Fiaspinsulin aspart injectionNovo NordiskBLACurrent
0169-3204Fiaspinsulin aspart injectionNovo NordiskBLACurrent
0169-3204Fiaspinsulin aspart injectionNovo NordiskNDACurrent
0169-3204Fiaspinsulin aspart injectionNovo NordiskNDACurrent
0169-3204Fiaspinsulin aspart injectionNovo NordiskNDACurrent
0169-3204Fiaspinsulin aspart injectionNovo NordiskNDACurrent
0169-3204Fiaspinsulin aspart injectionNovo NordiskNDACurrent
0169-3204Fiaspinsulin aspart injectionNovo NordiskBLACurrent
0169-3204Fiaspinsulin aspart injectionNovo NordiskBLACurrent
0169-3204Fiaspinsulin aspart injectionNovo NordiskNDACurrent
0169-3204Fiaspinsulin aspart injectionNovo NordiskBLACurrent
0169-3205Fiaspinsulin aspart injectionNovo NordiskBLACurrent
0169-3205Fiaspinsulin aspart injectionNovo NordiskNDACurrent
0169-3205Fiaspinsulin aspart injectionNovo NordiskNDACurrent
0169-3205Fiaspinsulin aspart injectionNovo NordiskNDACurrent
0169-3205Fiaspinsulin aspart injectionNovo NordiskNDACurrent
0169-3205Fiaspinsulin aspart injectionNovo NordiskNDACurrent
0169-3205Fiaspinsulin aspart injectionNovo NordiskBLACurrent
0169-3205Fiaspinsulin aspart injectionNovo NordiskBLACurrent
0169-3205Fiaspinsulin aspart injectionNovo NordiskNDACurrent
0169-3205Fiaspinsulin aspart injectionNovo NordiskBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74609SUPPL 2023-06-22
74583SUPPL 2023-06-22
62398APPL2020-03-31
61422SUPPL2020-03-23
61421SUPPL2020-03-23
61399SUPPL2020-03-23
61398SUPPL2020-03-23
60952SUPPL2020-03-23
60861SUPPL2020-03-23
60641SUPPL2020-03-23
60640SUPPL2020-03-23
60629SUPPL2020-03-23
60628SUPPL2020-03-23
55747SUPPL2020-03-23
55455SUPPL2020-03-23
55380SUPPL2020-03-23
53875ORIG2020-03-23
53008SUPPL2020-03-23
52858SUPPL2020-03-23
49906ORIG2020-03-23
49903ORIG2020-03-23
63070SUPPL1900-01-01
63069SUPPL1900-01-01
63068SUPPL1900-01-01
63067SUPPL1900-01-01