Treats infections caused by susceptible isolates of the designated microorganisms in the…. NDA 21537, held by Sandoz. Ciprofloxacin; Dexamethasone.
As of Nov 14, 2026, NDA 21537 (Ciprodex), held by Sandoz, was first approved by FDA on Jul 18, 2003, with 6 approved supplements and 0 published complete response letters.
Ciprofloxacin and dexamethasone otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 18, 2003 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ciprodex0.3%;0.1% · suspension/drops;otic | Ciprofloxacin; Dexamethasone | RxReference drug |
| May 27, 2022 | Supplement 19Manufacturing | Approved | |
| Nov 3, 2020 | Supplement 18Labeling · Standard review | Approved | |
| Feb 21, 2019 | Supplement 17Labeling · Standard review | Approved | |
| Dec 10, 2015 | Supplement 12Labeling · Standard review | Approved | |
| May 22, 2013 | Supplement 8Manufacturing · Standard review | Approved | |
| Mar 1, 2004 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 18, 2003 | Original applicationNew dosage form · 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
