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FDA BLA · BLA761156

SOGROYA

somapacitan-beco

Sponsor: NOVO NORDISK INC

APPLICATION
BLA761156
TYPE
BLA
ORIGINAL APPROVAL
2020-08-28
LATEST ACTION
2026-02-27
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

SOGROYAPrescription
SOMAPACITAN-BECO 10MG/1.5ML · SOLUTION · SUBCUTANEOUS

Approval history

2026-02-27Efficacy · Supplement 15 · standard — Letter ↗AP
2026-02-27Efficacy · Supplement 14 · standard — Letter ↗AP
2026-02-27Efficacy · Supplement 12 · standard — Letter ↗AP
2025-07-09Labeling · Supplement 13 · standard — Letter ↗AP
2025-01-31Labeling · Supplement 6 · standard — Label ↗AP
2023-04-28Efficacy · Supplement 5 · standard — Letter ↗AP
2021-10-01Labeling · Supplement 2 · standard — Label ↗AP
2021-10-01Labeling · Supplement 1 · standard — Label ↗AP
2020-08-28Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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