Macitentan
ANDA 211000, held by Amneal. Macitentan.
- First approved: Jun 8, 2026
- Review: Standard
- Supplements approved: 0
- Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 8, 2026 | Original application | Approved |
Products
1 strengths and forms| Product | Active ingredient | Marketing |
|---|---|---|
| Macitentan10MG · tablet;oral | Macitentan | Rx |
Identifiers
- Application
- ANDA 211000
- Drugs@FDA
- Overview at FDA
- Company
- Amneal Pharmaceuticals
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters