Home Applications 208583 Application 208583
Type BLA
Sponsor NOVO Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 208583 Xultophy 100/3.6 insulin degludec and liraglutide 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 XULTOPHY 100/3.6 INSULIN DEGLUDEC; LIRAGLUTIDE SOLUTION;SUBCUTANEOUS 300 UNITS/3ML;10.8MG/3ML (100 UNITS/ML;3.6MG/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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0169-2911 Xultophy 100/3.6 (insulin degludec and liraglutide) Novo Nordisk NDA Current 0169-2911 Xultophy 100/3.6 (insulin degludec and liraglutide) Novo Nordisk BLA Current 0169-2911 Xultophy 100/3.6 (insulin degludec and liraglutide) Novo Nordisk BLA Current 0169-2911 Xultophy 100/3.6 (insulin degludec and liraglutide) Novo Nordisk NDA Current 0169-2911 Xultophy 100/3.6 (insulin degludec and liraglutide) Novo Nordisk NDA Current