ANDA 203384, held by Chartwell Rx. Epinastine Hydrochloride.
As of Nov 15, 2026, ANDA 203384 (Epinastine Hydrochloride), held by Chartwell Rx, was first approved by FDA on Dec 7, 2016, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 7, 2016 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Epinastine Hydrochloride0.05% ยท solution/drops;ophthalmic | Epinastine Hydrochloride | Discontinued |
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
