FDA.reportPublic FDA data

Application 208583

Type
BLA
Sponsor
NOVO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XULTOPHY 100/3.6INSULIN DEGLUDEC; LIRAGLUTIDESOLUTION;SUBCUTANEOUS300 UNITS/3ML;10.8MG/3ML (100 UNITS/ML;3.6MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0169-2911Xultophy 100/3.6(insulin degludec and liraglutide)Novo NordiskBLACurrent
0169-2911Xultophy 100/3.6(insulin degludec and liraglutide)Novo NordiskBLACurrent
0169-2911Xultophy 100/3.6(insulin degludec and liraglutide)Novo NordiskNDACurrent
0169-2911Xultophy 100/3.6(insulin degludec and liraglutide)Novo NordiskNDACurrent
0169-2911Xultophy 100/3.6(insulin degludec and liraglutide)Novo NordiskNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83785SUPPL 2025-10-15
83784SUPPL 2025-10-15
83773SUPPL 2025-10-15
82369SUPPL 2025-05-30
82347SUPPL 2025-05-29
80124SUPPL 2024-11-05
80111SUPPL 2024-11-04
74727SUPPL 2023-07-12
74719SUPPL 2023-07-11
71291SUPPL2022-06-13
71290SUPPL2022-06-13
71289SUPPL2022-06-13
71274SUPPL2022-06-13
71273SUPPL2022-06-13
62410APPL2020-04-01
60951SUPPL2020-03-23
60950SUPPL2020-03-23
60924SUPPL2020-03-23
60922SUPPL2020-03-23
60920SUPPL2020-03-23
60918SUPPL2020-03-23
59662SUPPL2020-03-23
59647SUPPL2020-03-23
59644SUPPL2020-03-23
57847SUPPL2020-03-23
57846SUPPL2020-03-23
57845SUPPL2020-03-23
57839SUPPL2020-03-23
57838SUPPL2020-03-23
57837SUPPL2020-03-23
57567SUPPL2020-03-23
57566SUPPL2020-03-23
57432SUPPL2020-03-23
57431SUPPL2020-03-23
57430SUPPL2020-03-23
57429SUPPL2020-03-23
50744SUPPL2020-03-23
50487ORIG2020-03-23
50050APPL2020-03-23
45933ORIG2020-03-23
45928ORIG2020-03-23