ANDA 211107, held by Torrent. Macitentan.
As of Nov 13, 2026, ANDA 211107 (Macitentan), held by Torrent, was first approved by FDA on Aug 5, 2024, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 5, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Macitentan10MG ยท tablet;oral | Macitentan | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 2, 2025 | Supplement 2REMS | Approved | None posted |
| Dec 12, 2024 | Supplement 1REMS | Approved | None posted |
| Aug 5, 2024 | Original application | Approved | None posted |
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
