FDA.reportPublic FDA data

Application 206321

Type
NDA
Sponsor
NOVO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SAXENDALIRAGLUTIDE RECOMBINANTSOLUTION;SUBCUTANEOUS18MG/3ML (6MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0169-2800SaxendaliraglutideNovo NordiskNDACurrent
0169-2800SaxendaliraglutideNovo NordiskNDACurrent
0169-2800SaxendaliraglutideNovo NordiskNDACurrent
0169-2800SaxendaliraglutideNovo NordiskNDACurrent
0169-2800SaxendaliraglutideNovo NordiskNDACurrent
0169-2800SaxendaliraglutideNovo NordiskNDACurrent
50090-4257SaxendaliraglutideA-S Medication SolutionsNDACurrent
50090-4257SaxendaliraglutideA-S Medication SolutionsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85188SUPPL 2026-03-02
85176SUPPL 2026-02-27
83789SUPPL 2025-10-15
83788SUPPL 2025-10-15
83772SUPPL 2025-10-15
82359SUPPL 2025-05-30
82345SUPPL 2025-05-29
80122SUPPL 2024-11-05
80103SUPPL 2024-11-04
74045SUPPL 2023-04-24
74037SUPPL 2023-04-21
71345SUPPL2022-06-16
71344SUPPL2022-06-16
71336SUPPL2022-06-16
65553SUPPL2020-12-09
65552SUPPL2020-12-09
65551SUPPL2020-12-09
65527SUPPL2020-12-08
65526SUPPL2020-12-08
65525SUPPL2020-12-08
62344SUPPL2020-03-26
62342SUPPL2020-03-26
62341SUPPL2020-03-26
58926SUPPL2019-06-03
56665SUPPL2018-12-07
56080SUPPL2018-10-23
56050SUPPL2018-10-22
48614SUPPL2017-06-01
48208SUPPL2017-05-02
48207SUPPL2017-05-02
48126SUPPL2017-04-27
48125SUPPL2017-04-27
48124SUPPL2017-04-27
48123SUPPL2017-04-27
45520SUPPL2016-10-12
45412SUPPL2016-09-29
32797SUPPL2016-02-02
43516ORIG2015-10-01
19715SUPPL2015-04-01
32796SUPPL2015-03-31
44600ORIG2014-12-31
40537ORIG2014-12-31
10560ORIG2014-12-31