ANDA 211198, held by Aurobindo Pharma Ltd. Macitentan.
As of Nov 13, 2026, ANDA 211198 (Macitentan), held by Aurobindo Pharma Ltd, was first approved by FDA on Apr 18, 2023, with 6 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 18, 2023 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Macitentan10MG · tablet;oral | Macitentan | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 5, 2025 | Supplement 5Labeling · Standard review | Approved | None posted |
| Sep 5, 2025 | Supplement 6Labeling · Standard review | Approved | None posted |
| Apr 2, 2025 | Supplement 4REMS | Approved | None posted |
| Dec 12, 2024 | Supplement 3REMS | Approved | None posted |
| May 29, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Apr 11, 2024 | Supplement 2REMS | Approved | None posted |
| Apr 18, 2023 | Original application | Approved |
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
