ANDA 206987, held by Natco Pharma Ltd. Bosentan.
As of Nov 14, 2026, ANDA 206987 (Bosentan), held by Natco Pharma Ltd, was first approved by FDA on Apr 26, 2019, with 6 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 26, 2019 | Original application | Approved |
| Oct 27, 2026 | Supplement 12REMS | Approved | None posted |
| Mar 3, 2026 | Supplement 11REMS | Approved | None posted |
| Nov 5, 2025 | Supplement 7REMS | Approved | None posted |
| Feb 21, 2025 | Supplement 6REMS | Approved | None posted |
| Sep 17, 2024 | Supplement 5REMS | Approved | None posted |
| Apr 29, 2022 | Supplement 4REMS | Approved | None posted |
| Apr 26, 2019 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
