NDA 215352, held by Eyenovia. Phenylephrine Hydrochloride; Tropicamide.
As of Nov 13, 2026, NDA 215352 (Mydcombi), held by Eyenovia, was first approved by FDA on May 5, 2023, with 0 approved supplements and 1 published complete response letter.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 5, 2023 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Oct 22, 2021 | NDA 215352 | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mydcombi2.5%;1% · spray, metered;ophthalmic | Phenylephrine Hydrochloride; Tropicamide | DiscontinuedReference drug |
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
