← FDA Drug Approvals (Drugs@FDA)
MODEYSO
NDA · New Drug Application · Sponsor: CHIMERIX · Approved 2025-08-06
Drug application
- FDA Application #
NDA219876- Application type
- New Drug Application
- Brand name
- MODEYSO
- Generic name
- DORDAVIPRONE
- Active ingredients
- DORDAVIPRONE HYDROCHLORIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- CHIMERIX
- Manufacturer
- Jazz Pharmaceuticals, Inc.
- First approval
- 2025-08-06
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown