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Sogroya
somapacitan-beco
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Sogroya
Proper name
somapacitan-beco
Licence type
351(a)
BLA number
761156
Applicant
Novo Nordisk Inc.
Center
CDER
Presentations
3
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10MG/1.5ML (6.7MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | August 28, 2020 |
| 15MG/1.5ML (10MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | April 28, 2023 |
| 5MG/1.5ML (3.3MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | October 1, 2021 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |