Home Applications 208751 Application 208751
Type BLA
Sponsor NOVO Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 208751 Fiasp insulin aspart 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FIASP INSULIN ASPART SOLUTION;INTRAVENOUS, SUBCUTANEOUS 1000 UNITS/10ML (100 UNITS/ML) No No 002 FIASP FLEXTOUCH INSULIN ASPART SOLUTION;SUBCUTANEOUS 300 UNITS/3ML (100 UNITS/ML) No No 003 FIASP PENFILL INSULIN ASPART SOLUTION;SUBCUTANEOUS 300 UNITS/3ML (100 UNITS/ML) No No
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.
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NDC Listings For This Application# NDC listings for this application page 1 of 1 · 30 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0169-3201 Fiasp insulin aspart injection Novo Nordisk BLA Current 0169-3201 Fiasp insulin aspart injection Novo Nordisk NDA Current 0169-3201 Fiasp insulin aspart injection Novo Nordisk NDA Current 0169-3201 Fiasp insulin aspart injection Novo Nordisk NDA Current 0169-3201 Fiasp insulin aspart injection Novo Nordisk NDA Current 0169-3201 Fiasp insulin aspart injection Novo Nordisk NDA Current 0169-3201 Fiasp insulin aspart injection Novo Nordisk BLA Current 0169-3201 Fiasp insulin aspart injection Novo Nordisk BLA Current 0169-3201 Fiasp insulin aspart injection Novo Nordisk NDA Current 0169-3201 Fiasp insulin aspart injection Novo Nordisk BLA Current 0169-3204 Fiasp insulin aspart injection Novo Nordisk BLA Current 0169-3204 Fiasp insulin aspart injection Novo Nordisk NDA Current 0169-3204 Fiasp insulin aspart injection Novo Nordisk NDA Current 0169-3204 Fiasp insulin aspart injection Novo Nordisk NDA Current 0169-3204 Fiasp insulin aspart injection Novo Nordisk NDA Current 0169-3204 Fiasp insulin aspart injection Novo Nordisk NDA Current 0169-3204 Fiasp insulin aspart injection Novo Nordisk BLA Current 0169-3204 Fiasp insulin aspart injection Novo Nordisk BLA Current 0169-3204 Fiasp insulin aspart injection Novo Nordisk NDA Current 0169-3204 Fiasp insulin aspart injection Novo Nordisk BLA Current 0169-3205 Fiasp insulin aspart injection Novo Nordisk BLA Current 0169-3205 Fiasp insulin aspart injection Novo Nordisk NDA Current 0169-3205 Fiasp insulin aspart injection Novo Nordisk NDA Current 0169-3205 Fiasp insulin aspart injection Novo Nordisk NDA Current 0169-3205 Fiasp insulin aspart injection Novo Nordisk NDA Current 0169-3205 Fiasp insulin aspart injection Novo Nordisk NDA Current 0169-3205 Fiasp insulin aspart injection Novo Nordisk BLA Current 0169-3205 Fiasp insulin aspart injection Novo Nordisk BLA Current 0169-3205 Fiasp insulin aspart injection Novo Nordisk NDA Current 0169-3205 Fiasp insulin aspart injection Novo Nordisk BLA Current