Ciloxan

Treats infections caused by susceptible strains of the designated microorganisms in the…. NDA 19992, held by Sandoz. Ciprofloxacin Hydrochloride.

As of Nov 14, 2026, NDA 19992 (Ciloxan), held by Sandoz, was first approved by FDA on Dec 31, 1990, with 19 approved supplements and 0 published complete response letters.

First approved: Dec 31, 1990
Review: Standard
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Ciprofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below: Corneal Ulcers: Pseudomonas aeruginosa Serratia marcescens* Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Streptococcus (Viridans Group)* Conjunctivitis: Haemophilus influenzae Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae *Efficacy for this organism was studied in fewer than 10 infections.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below


Oct 27, 1994	Supplement 4Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 31, 1990	Original applicationNew dosage form · Standard review	Approved	Pediatric Medical Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
CiloxanEQ 0.3% BASE · solution/drops;ophthalmic	Ciprofloxacin Hydrochloride	RxReference drug

All 20 submissions, including labeling and manufacturing supplements


Mar 21, 2017	Supplement 26Labeling · Standard review	Approved	Letter Label
Feb 7, 2006	Supplement 20Labeling · Standard review	Approved	Letter Label
Aug 20, 2004	Supplement 19Labeling · Standard review	Approved	Letter Label
Mar 13, 2002	Supplement 16Manufacturing · Standard review	Approved	None posted
Sep 14, 2001	Supplement 15Manufacturing · Standard review	Approved	None posted
Mar 16, 2001	Supplement 14Manufacturing · Standard review	Approved	None posted
Feb 18, 2000	Supplement 13Manufacturing · Standard review	Approved	None posted
Nov 9, 1999	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 17, 1999	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 11, 1999	Supplement 10Manufacturing · Standard review	Approved	None posted
Feb 5, 1999	Supplement 11Manufacturing · Standard review	Approved	None posted
Oct 14, 1998	Supplement 9Manufacturing · Standard review	Approved	None posted
Jan 15, 1998	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 1, 1995	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 1, 1995	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 27, 1994	Supplement 4Efficacy (new indication or use) · Standard review	Approved	None posted
Oct 27, 1993	Supplement 2Manufacturing · Standard review	Approved	None posted
Jan 22, 1993	Supplement 3Manufacturing · Standard review	Approved	None posted
Feb 12, 1992	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 31, 1990	Original applicationNew dosage form · Standard review	Approved	Pediatric Medical Review

Identifiers

Application: NDA 19992
Drugs@FDA: Overview at FDA
Company: Sandoz

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