Ciprofloxacin, Ciprofloxacin Hydrochloride

ANDA 76089, held by Ivax Sub Teva Pharms. Ciprofloxacin, Ciprofloxacin Hydrochloride.

As of Nov 15, 2026, ANDA 76089 (Ciprofloxacin, Ciprofloxacin Hydrochloride), held by Ivax Sub Teva Pharms, was first approved by FDA on Jun 9, 2004, with 22 approved supplements and 0 published complete response letters.

First approved: Jun 9, 2004
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Jun 9, 2004	Original application	Approved	Letter

Products

4 strengths and forms


Ciprofloxacin100MG · tablet; oral	Ciprofloxacin	None (tentative approval)
Ciprofloxacin HydrochlorideEQ 250MG BASE · tablet;oral	Ciprofloxacin Hydrochloride	Rx
Ciprofloxacin HydrochlorideEQ 500MG BASE · tablet;oral	Ciprofloxacin Hydrochloride	Rx
Ciprofloxacin HydrochlorideEQ 750MG BASE · tablet;oral	Ciprofloxacin Hydrochloride	Rx

All 23 submissions, including labeling and manufacturing supplements


May 19, 2026	Supplement 54Labeling · Standard review	Approved	None posted
Dec 19, 2022	Supplement 44Labeling · Standard review	Approved	None posted
Dec 19, 2022	Supplement 46Labeling · Standard review	Approved	None posted
Dec 19, 2022	Supplement 48Labeling · Standard review	Approved	None posted
Dec 19, 2022	Supplement 49Labeling · Standard review	Approved	None posted
Dec 19, 2022	Supplement 51Labeling · Standard review	Approved	None posted
Dec 19, 2022	Supplement 52Labeling · Standard review	Approved	None posted
Dec 19, 2022	Supplement 53Labeling · Standard review	Approved	None posted
Apr 19, 2016	Supplement 45Labeling · Standard review	Approved	None posted
Apr 24, 2013	Supplement 42Labeling · Standard review	Approved	None posted
Mar 13, 2012	Supplement 40Labeling	Approved	None posted
Nov 28, 2011	Supplement 38Labeling	Approved	None posted
May 8, 2011	Supplement 37Labeling	Approved	None posted
Sep 28, 2009	Supplement 31Labeling	Approved	None posted
May 20, 2009	Supplement 29Labeling	Approved	None posted
Dec 2, 2008	Supplement 28Labeling	Approved	None posted
Mar 16, 2008	Supplement 27Labeling	Approved	None posted
Mar 10, 2008	Supplement 22Labeling	Approved	None posted
Feb 29, 2008	Supplement 24Labeling	Approved	None posted
Feb 6, 2008	Supplement 26Labeling	Approved	None posted
Oct 22, 2006	Supplement 19Labeling	Approved	None posted
Nov 29, 2005	Supplement 15Labeling	Approved	None posted
Jun 9, 2004	Original application	Approved	Letter

Identifiers

Application: ANDA 76089
Drugs@FDA: Overview at FDA
Company: IVAX Pharmaceuticals

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