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Skytrofa
lonapegsomatropin-tcgd
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Skytrofa
Proper name
lonapegsomatropin-tcgd
Licence type
351(a)
BLA number
761177
Applicant
Ascendis Pharma Endocrinology Division A/S
Center
CDER
Presentations
14
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 0.7MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | July 25, 2025 |
| 1.4MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | July 25, 2025 |
| 1.8MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | July 25, 2025 |
| 11MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | August 25, 2021 |
| 13.3MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | August 25, 2021 |
| 2.1MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | July 25, 2025 |
| 2.5MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | July 25, 2025 |
| 3.6MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | August 25, 2021 |
| 3MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | August 25, 2021 |
| 4.3MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | August 25, 2021 |
| 5.2MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | August 25, 2021 |
| 6.3MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | August 25, 2021 |
| 7.6MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | August 25, 2021 |
| 9.1MG | For Injection | Subcutaneous | Single-Dose Cartridge | Rx | August 25, 2021 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |