For keratoconjunctivitis sicca (dry eye). NDA 210913, held by Sun Pharm. Cyclosporine.
As of Nov 13, 2026, NDA 210913 (Cequa), held by Sun Pharm, was first approved by FDA on Aug 14, 2018, with 1 approved supplement and 0 published complete response letters.
CEQUA ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 14, 2018 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cequa0.09% · solution;ophthalmic | Cyclosporine | RxReference drug |
| Sep 20, 2019 | Supplement 2Labeling · Standard review | Approved | |
| Aug 14, 2018 | Original applicationNew formulation or manufacturer · Standard review | 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
