Application 761156

Type: ANDA
Sponsor: NOVO NORDISK INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SOGROYA	SOMPACITAN-BECO	INJECTABLE;INJECTION	10MG/1.5ML	No	No

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SOGROYA	SOMAPACITAN-BECO	Novo Nordisk	eadd03b4-adc3-4b88-8a24-9d205c5b85aa	2026-02-25	Warnings, Adverse reactions	Exact identifier ndc (product): 0169-2030 ndc (product): 0169-2035

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0169-2030	SOGROYA	somapacitan-beco	Novo Nordisk	BLA	Current
0169-2030	SOGROYA	somapacitan-beco	Novo Nordisk	BLA	Current
0169-2030	SOGROYA	somapacitan-beco	Novo Nordisk	BLA	Current
0169-2035	SOGROYA	somapacitan-beco	Novo Nordisk	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85284	SUPPL	2026-03-06
85283	SUPPL	2026-03-06
85282	SUPPL	2026-03-06
85217	SUPPL	2026-03-03
85216	SUPPL	2026-03-03
85215	SUPPL	2026-03-03
82798	SUPPL	2025-07-11
82778	SUPPL	2025-07-11
81106	SUPPL	2025-02-06
81081	SUPPL	2025-02-06
74134	SUPPL	2023-05-01
74126	SUPPL	2023-05-01
68883	SUPPL	2021-10-05
68882	SUPPL	2021-10-05
68852	SUPPL	2021-10-01
68851	SUPPL	2021-10-01
64695	ORIG	2020-09-28
64494	ORIG	2020-09-04
64459	ORIG	2020-09-01