# TRACLEER
> **NDA021290** · New Drug Application · Sponsor: ACTELION · Approved 2001-11-20
## Drug
- **FDA Application Number:** NDA021290
- **Application type:** New Drug Application
- **Brand name:** TRACLEER
- **Generic name:** BOSENTAN
- **Active ingredients:** BOSENTAN
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ACTELION
- **Manufacturer:** Actelion Pharmaceuticals US, Inc.
- **First approval:** 2001-11-20
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021290)
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*MORVS · CC0 1.0*