ANDA 211943, held by Saptalis Pharms. Cyclosporine.
As of Nov 15, 2026, ANDA 211943 (Cyclosporine), held by Saptalis Pharms, was first approved by FDA on Jul 5, 2024, with 0 approved supplements and 0 published complete response letters.
1 IN DICATIONS AND USAGE Cyclosporine ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. Cyclosporine is a calcineurin inhibitor immunosuppressant
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 5, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cyclosporine0.05% · emulsion;ophthalmic | Cyclosporine | Rx |
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
