NDA 208032, held by St Renatus. Oxymetazoline Hydrochloride; Tetracaine Hydrochloride.
As of Nov 13, 2026, NDA 208032 (Kovanaze), held by St Renatus, was first approved by FDA on Jun 29, 2016, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 29, 2016 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Kovanaze0.1MG/SPRAY;6MG/SPRAY · spray, metered;nasal | Oxymetazoline Hydrochloride; Tetracaine Hydrochloride | RxReference drug |
| Nov 2, 2018 | Supplement 4Labeling · Standard review | Approved | |
| Jun 29, 2016 | Original applicationNew combination · 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
