FDA.reportPublic FDA data

Application 761156

Type
ANDA
Sponsor
NOVO NORDISK INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SOGROYASOMPACITAN-BECOINJECTABLE;INJECTION10MG/1.5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0169-2030SOGROYAsomapacitan-becoNovo NordiskBLACurrent
0169-2030SOGROYAsomapacitan-becoNovo NordiskBLACurrent
0169-2030SOGROYAsomapacitan-becoNovo NordiskBLACurrent
0169-2035SOGROYAsomapacitan-becoNovo NordiskBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85284SUPPL 2026-03-06
85283SUPPL 2026-03-06
85282SUPPL 2026-03-06
85217SUPPL 2026-03-03
85216SUPPL 2026-03-03
85215SUPPL 2026-03-03
82798SUPPL 2025-07-11
82778SUPPL 2025-07-11
81106SUPPL 2025-02-06
81081SUPPL 2025-02-06
74134SUPPL 2023-05-01
74126SUPPL 2023-05-01
68883SUPPL2021-10-05
68882SUPPL2021-10-05
68852SUPPL2021-10-01
68851SUPPL2021-10-01
64695ORIG2020-09-28
64494ORIG2020-09-04
64459ORIG2020-09-01