# OPSYNVI
> **NDA218490** · New Drug Application · Sponsor: ACTELION · Approved 2024-03-22
## Drug
- **FDA Application Number:** NDA218490
- **Application type:** New Drug Application
- **Brand name:** OPSYNVI
- **Generic name:** MACITENTAN AND TADALAFIL
- **Active ingredients:** MACITENTAN; TADALAFIL
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ACTELION
- **Manufacturer:** Actelion Pharmaceuticals US, Inc.
- **First approval:** 2024-03-22
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218490)
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*MORVS · CC0 1.0*