Treats acute otitis externa. NDA 20805, held by Sandoz. Ciprofloxacin Hydrochloride; Hydrocortisone.
As of Nov 13, 2026, NDA 20805 (Cipro Hc), held by Sandoz, was first approved by FDA on Feb 10, 1998, with 8 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE CIPRO HC OTIC is indicated for the treatment of acute otitis externa in adult and pediatric patients, one year and older, due to susceptible strains of Pseudomonas aeruginosa, Staphylococcus aureus, and Proteus mirabilis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 10, 1998 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cipro HcEQ 0.2% BASE;1% · suspension/drops;otic | Ciprofloxacin Hydrochloride; Hydrocortisone | RxReference drug |
| Mar 20, 2017 | Supplement 11Labeling · Standard review | Approved | |
| Jul 9, 2013 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Mar 13, 2002 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Apr 19, 2001 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Feb 27, 2001 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Oct 14, 1999 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 17, 1998 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Sep 15, 1998 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Feb 10, 1998 | 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
