NDA 208912, held by Eyepoint Pharms. Dexamethasone.
As of Nov 13, 2026, NDA 208912 (Dexycu Kit), held by Eyepoint Pharms, was first approved by FDA on Feb 9, 2018, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 9, 2018 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dexycu Kit9% · suspension;intraocular | Dexamethasone | DiscontinuedReference drug |
| Jun 4, 2020 | Supplement 2Labeling · Standard review | Approved | |
| Feb 9, 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
