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

Source provenance: Browse the complete Orange Book source catalog.

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SOGROYASOMAPACITAN-BECONovo Nordiskeadd03b4-adc3-4b88-8a24-9d205c5b85aa2026-02-25Warnings, Adverse reactionsExact identifier
ndc (product): 0169-2030
ndc (product): 0169-2035

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

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