Cetraxal

NDA 21918, held by Lab Salvat. Ciprofloxacin Hydrochloride.

As of Nov 14, 2026, NDA 21918 (Cetraxal), held by Lab Salvat, was first approved by FDA on May 1, 2009, with 1 approved supplement and 0 published complete response letters.

First approved: May 1, 2009
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
May 1, 2009	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
CetraxalEQ 0.2% BASE · solution/drops;otic	Ciprofloxacin Hydrochloride	RxReference drug

All 2 submissions, including labeling and manufacturing supplements


Oct 30, 2026	Supplement 5Labeling · Standard review	Approved	Letter Label
May 1, 2009	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 21918
Drugs@FDA: Overview at FDA
Company: Lab Salvat

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