Ciprofloxacin, Ciprofloxacin Hydrochloride

Treats skin and skin structure infections caused by Escherichia coli, Klebsiella…. ANDA 76558, held by Hikma. Ciprofloxacin, Ciprofloxacin Hydrochloride.

As of Nov 15, 2026, ANDA 76558 (Ciprofloxacin, Ciprofloxacin Hydrochloride), held by Hikma, was first approved by FDA on Jun 9, 2004, with 28 approved supplements and 0 published complete response letters.

First approved: Jun 9, 2004
Supplements approved: 28
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Ciprofloxacin tablets are a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated:

Skin and Skin Structure Infections
Bone and Joint Infections
Complicated Intra-Abdominal Infections
Infectious Diarrhea
Typhoid Fever (Enteric Fever)
Uncomplicated Cervical and Urethral Gonorrhea
Inhalational Anthrax post-exposure in adult and pediatric patients
Plague in adult and pediatric patients
Chronic Bacterial Prostatitis
Lower Respiratory Tract Infections o Acute Exacerbation of Chronic Bronchitis
Urinary Tract Infections o Urinary Tract Infec…

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 29 submissions below

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

Products

4 strengths and forms


Ciprofloxacin250MG · tablet; oral	Ciprofloxacin	Rx
Ciprofloxacin HydrochlorideEQ 250MG BASE · tablet;oral	Ciprofloxacin Hydrochloride	Discontinued
Ciprofloxacin HydrochlorideEQ 500MG BASE · tablet;oral	Ciprofloxacin Hydrochloride	Discontinued
Ciprofloxacin HydrochlorideEQ 750MG BASE · tablet;oral	Ciprofloxacin Hydrochloride	Discontinued

All 29 submissions, including labeling and manufacturing supplements


Jul 22, 2026	Supplement 72Labeling · Standard review	Approved	None posted
Aug 31, 2023	Supplement 63Labeling · Standard review	Approved	None posted
Aug 31, 2023	Supplement 59Labeling · Standard review	Approved	None posted
Aug 31, 2023	Supplement 56Labeling · Standard review	Approved	None posted
Aug 31, 2023	Supplement 55Labeling · Standard review	Approved	None posted
Aug 31, 2023	Supplement 53Labeling · Standard review	Approved	None posted
Aug 31, 2023	Supplement 51Labeling · Standard review	Approved	None posted
Aug 31, 2023	Supplement 49Labeling · Standard review	Approved	None posted
Nov 7, 2018	Supplement 46Labeling · Standard review	Approved	None posted
Nov 7, 2018	Supplement 41Labeling · Standard review	Approved	None posted
Sep 21, 2015	Supplement 38Labeling · Standard review	Approved	None posted
Sep 21, 2015	Supplement 36Labeling · Standard review	Approved	None posted
Sep 21, 2015	Supplement 35Labeling · Standard review	Approved	None posted
Oct 31, 2014	Supplement 22Manufacturing	Approved	None posted
Aug 15, 2012	Supplement 34Labeling · Standard review	Approved	None posted
Jul 11, 2012	Supplement 33Labeling	Approved	None posted
Feb 28, 2012	Supplement 31Labeling	Approved	None posted
May 12, 2011	Supplement 27Labeling	Approved	None posted
May 8, 2011	Supplement 28Labeling	Approved	None posted
Aug 24, 2009	Supplement 21Labeling	Approved	None posted
Aug 20, 2009	Supplement 19Labeling	Approved	None posted
Feb 4, 2009	Supplement 4Labeling	Approved	None posted
Jan 29, 2009	Supplement 17Labeling	Approved	None posted
Mar 16, 2008	Supplement 14Labeling	Approved	None posted
Feb 6, 2008	Supplement 13Labeling	Approved	None posted
Feb 9, 2007	Supplement 12Labeling	Approved	None posted
Nov 29, 2005	Supplement 8Labeling	Approved	None posted
Jun 29, 2005	Supplement 7Labeling	Approved	None posted
Jun 9, 2004	Original application	Approved	Letter

Identifiers

Application: ANDA 76558
Drugs@FDA: Overview at FDA
Company: Hikma

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