FdaApplication
BLA 761177
Identifiers
- fda_app_no: BLA761177
Properties
| Property | Value |
|---|---|
| applicant_name | Ascendis Pharma Endocrinology Division A/S |
| application_type | BLA |
| approval_date | 2021-08-25 |
Products (14)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| SKYTROFA | LONAPEGSOMATROPIN-TCGD | 6.3MG | For Injection |
| SKYTROFA | LONAPEGSOMATROPIN-TCGD | 9.1MG | For Injection |
| SKYTROFA | LONAPEGSOMATROPIN-TCGD | 7.6MG | For Injection |
| SKYTROFA | LONAPEGSOMATROPIN-TCGD | 5.2MG | For Injection |
| SKYTROFA | LONAPEGSOMATROPIN-TCGD | 13.3MG | For Injection |
| SKYTROFA | LONAPEGSOMATROPIN-TCGD | 4.3MG | For Injection |
| SKYTROFA | LONAPEGSOMATROPIN-TCGD | 3MG | For Injection |
| SKYTROFA | LONAPEGSOMATROPIN-TCGD | 11MG | For Injection |
| SKYTROFA | LONAPEGSOMATROPIN-TCGD | 3.6MG | For Injection |
| SKYTROFA | — | 2.1MG | For Injection |
| SKYTROFA | — | 1.4MG | For Injection |
| SKYTROFA | — | 2.5MG | For Injection |
| SKYTROFA | — | 1.8MG | For Injection |
| SKYTROFA | — | 0.7MG | For Injection |
14 products