← FDA Drug Approvals (Drugs@FDA)
SKYTROFA
BLA · Biologics License Application · Sponsor: ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S · Approved 2021-08-25
Drug application
- FDA Application #
BLA761177
- Application type
- Biologics License Application
- Brand name
- SKYTROFA
- Generic name
- LONAPEGSOMATROPIN-TCGD
- Active ingredients
- LONAPEGSOMATROPIN-TCGD
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Prescription
- Sponsor
- ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S
- Manufacturer
- Ascendis Pharma Endocrinology, Inc.
- First approval
- 2021-08-25
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown