# MACITENTAN
> **ANDA211120** · Abbreviated New Drug Application (Generic) · Sponsor: LAURUS · Approved 2025-11-05
## Drug
- **FDA Application Number:** ANDA211120
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** MACITENTAN
- **Generic name:** Macitentan
- **Active ingredients:** MACITENTAN
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** LAURUS
- **First approval:** 2025-11-05
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211120)
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*MORVS · CC0 1.0*