NDA 21023, held by Allergan. Cyclosporine.
As of Nov 14, 2026, NDA 21023 (Restasis), held by Allergan, was first approved by FDA on Oct 10, 2003, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 10, 2003 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Restasis0.05% · 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
