Iquix

NDA 21571, held by Santen. Levofloxacin.

As of Nov 14, 2026, NDA 21571 (Iquix), held by Santen, was first approved by FDA on Mar 1, 2004, with 1 approved supplement and 0 published complete response letters.

First approved: Mar 1, 2004
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Mar 1, 2004	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Iquix1.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution/drops;ophthalmic	Levofloxacin	DiscontinuedReference drug

All 2 submissions, including labeling and manufacturing supplements


Dec 3, 2014	Supplement 6Labeling · Standard review	Approved	Label Letter
Mar 1, 2004	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21571
Drugs@FDA: Overview at FDA
Company: Santen, Inc.

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