NDA 208251, held by Lab Salvat. Ciprofloxacin Hydrochloride; Fluocinolone Acetonide.
As of Nov 13, 2026, NDA 208251 (Otovel), held by Lab Salvat, was first approved by FDA on Apr 29, 2016, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 29, 2016 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| OtovelEQ 0.3% BASE;0.025% · solution/drops;otic | Ciprofloxacin Hydrochloride; Fluocinolone Acetonide | RxReference 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
