ANDA 207606, held by Apotex. Cyclosporine.
As of Nov 15, 2026, ANDA 207606 (Cyclosporine), held by Apotex, was first approved by FDA on Jan 12, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 12, 2023 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cyclosporine0.05% ยท emulsion;ophthalmic | Cyclosporine | Discontinued |
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