# OPSUMIT
> **NDA204410** · New Drug Application · Sponsor: ACTELION · Approved 2013-10-18
## Drug
- **FDA Application Number:** NDA204410
- **Application type:** New Drug Application
- **Brand name:** OPSUMIT
- **Generic name:** MACITENTAN
- **Active ingredients:** MACITENTAN
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ACTELION
- **Manufacturer:** Actelion Pharmaceuticals US, Inc.
- **First approval:** 2013-10-18
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204410)
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