Ciprofloxacin Hydrochloride

Treats skin and skin structure infections caused by Escherichia coli, Klebsiella…. ANDA 76896, held by Chartwell. Ciprofloxacin Hydrochloride.

As of Nov 15, 2026, ANDA 76896 (Ciprofloxacin Hydrochloride), held by Chartwell, was first approved by FDA on Nov 4, 2004, with 22 approved supplements and 0 published complete response letters.

First approved: Nov 4, 2004
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Ciprofloxacin is 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 ◦ Acute Exacerbation of Chronic Bronchitis Urinary Tract Infections ◦ Urinary Tract Infections (UTI) ◦ Acute Uncomplicat…

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Nov 4, 2004	Original application	Approved	None posted

Products

3 strengths and forms


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


Sep 30, 2025	Supplement 20Labeling · Standard review	Approved	None posted
Sep 30, 2025	Supplement 21Labeling · Standard review	Approved	None posted
Sep 30, 2025	Supplement 22Labeling · Standard review	Approved	None posted
Sep 30, 2025	Supplement 23Labeling · Standard review	Approved	None posted
Sep 30, 2025	Supplement 27Labeling · Standard review	Approved	None posted
Sep 30, 2025	Supplement 29Labeling · Standard review	Approved	None posted
Sep 30, 2025	Supplement 18Labeling · Standard review	Approved	None posted
Sep 30, 2025	Supplement 19Labeling · Standard review	Approved	None posted
Oct 6, 2015	Supplement 16Labeling · Standard review	Approved	None posted
Oct 6, 2015	Supplement 17Labeling · Standard review	Approved	None posted
Apr 25, 2013	Supplement 15Labeling · Standard review	Approved	None posted
May 1, 2012	Supplement 14Labeling	Approved	None posted
Jan 11, 2012	Supplement 12Labeling	Approved	None posted
Mar 25, 2010	Supplement 11REMS	Approved	None posted
Jul 16, 2009	Supplement 10Labeling	Approved	None posted
Mar 20, 2009	Supplement 9Labeling	Approved	None posted
Sep 16, 2008	Supplement 8Labeling	Approved	None posted
Jul 23, 2007	Supplement 3Labeling	Approved	None posted
Jul 9, 2007	Supplement 4Labeling	Approved	None posted
Jul 9, 2007	Supplement 5Labeling	Approved	None posted
Jul 9, 2007	Supplement 6Labeling	Approved	None posted
Jun 29, 2005	Supplement 1Labeling	Approved	None posted
Nov 4, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 76896
Drugs@FDA: Overview at FDA
Company: Chartwell

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