Active ingredient
Bosentan
14 finished FDA listings contain Bosentan as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- BOSENTAN
- Dosage forms
- Tablet, Tablet, Coated, Tablet, Film Coated, Tablet, For Suspension
- Routes
- Oral
- Manufacturers / labelers
- 6
- Strengths listed
- 125 mg/1 · 32 mg/1 · 62.5 mg/1
- Brand names in FDA listings
- Tracleer
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 75207
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 021290 | ACTELION | 2001-11-20 | 2 |
| NDA 209279 | ACTELION | 2017-09-05 | 1 |
| ANDA 207110 | WATSON LABS INC | 2019-04-26 | 2 |
| ANDA 207760 | ZYDUS PHARMS | 2019-04-26 | 4 |
| ANDA 209324 | SUN PHARM | 2019-04-26 | 2 |
| ANDA 213154 | NATCO PHARMA LTD | 2025-02-05 | 1 |
| ANDA 213981 | ZYDUS PHARMS | 2026-02-17 | 2 |
Official labeling on DailyMed
- BOSENTAN TABLET, COATED [ZYDUS PHARMACEUTICALS USA INC.] · version 8 · 2026-06-04
- BOSENTAN TABLET, FOR SUSPENSION [ZYDUS PHARMACEUTICALS USA INC.] · version 1 · 2026-02-18
- BOSENTAN TABLET, FOR SUSPENSION [ZYDUS LIFESCIENCES LIMITED] · version 1 · 2026-02-18
- TRACLEER (BOSENTAN) TABLET, FILM COATED TRACLEER (BOSENTAN) TABLET, FOR SUSPENSION [ACTELION PHARMACEUTICALS US, INC.] · version 36 · 2026-01-23
- BOSENTAN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] · version 24 · 2025-12-31
- BOSENTAN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 9 · 2025-12-24
- BOSENTAN TABLET, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC. ] · version 7 · 2025-11-17
- BOSENTAN TABLET [ZYDUS LIFESCIENCES LIMITED] · version 6 · 2024-12-02
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.