Ciloxan

Treats bacterial conjunctivitis caused by susceptible strains of the microorganisms…. NDA 20369, held by Sandoz. Ciprofloxacin Hydrochloride.

As of Nov 13, 2026, NDA 20369 (Ciloxan), held by Sandoz, was first approved by FDA on Mar 30, 1998, with 12 approved supplements and 0 published complete response letters.

First approved: Mar 30, 1998
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE: CILOXAN (ciprofloxacin ophthalmic ointment) 0.3% is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the microorganisms listed below: Gram-Positive: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Streptococcus Viridans Group Gram-Negative: Haemophilus influenzae

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Mar 30, 1998	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
CiloxanEQ 0.3% BASE · ointment;ophthalmic	Ciprofloxacin Hydrochloride	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


Feb 17, 2017	Supplement 22Labeling · Standard review	Approved	Letter Label
Aug 5, 2016	Supplement 21Manufacturing · Standard review	Approved	None posted
Sep 9, 2015	Supplement 20Manufacturing · Standard review	Approved	None posted
Jul 15, 2004	Supplement 10Manufacturing · Standard review	Approved	Label Letter
Jul 15, 2004	Supplement 9Labeling · Standard review	Approved	Letter Label
Aug 19, 2003	Supplement 7Labeling · Standard review	Approved	Label Letter
Aug 19, 2003	Supplement 6Manufacturing · Standard review	Approved	Label Letter
Dec 11, 2000	Supplement 5Manufacturing · Standard review	Approved	None posted
Jul 7, 2000	Supplement 4Labeling · Standard review	Approved	None posted
Sep 28, 1999	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 7, 1999	Supplement 2Manufacturing · Standard review	Approved	None posted
Feb 5, 1999	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 30, 1998	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 20369
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