Ciprofloxacin, Ciprofloxacin Hydrochloride

Treats skin and skin structure infections caused by Escherichia coli, Klebsiella…. ANDA 76126, held by Carlsbad. Ciprofloxacin, Ciprofloxacin Hydrochloride.

As of Nov 15, 2026, ANDA 76126 (Ciprofloxacin, Ciprofloxacin Hydrochloride), held by Carlsbad, was first approved by FDA on Jun 9, 2004, with 8 approved supplements and 0 published complete response letters.

First approved: Jun 9, 2004
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Ciprofloxacin Tablets 250 mg, 500 mg, and 750 mg are a fluoroquinolone antibacterial indicated in adults (≥18 years of age) 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 (U…

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 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	Rx
Ciprofloxacin HydrochlorideEQ 500MG BASE · tablet;oral	Ciprofloxacin Hydrochloride	Rx
Ciprofloxacin HydrochlorideEQ 750MG BASE · tablet;oral	Ciprofloxacin Hydrochloride	Rx

All 9 submissions, including labeling and manufacturing supplements


Dec 1, 2015	Supplement 12Labeling · Standard review	Approved	None posted
Dec 1, 2015	Supplement 11Labeling · Standard review	Approved	None posted
Dec 17, 2012	Supplement 10Labeling · Standard review	Approved	None posted
May 24, 2012	Supplement 9Labeling · Standard review	Approved	None posted
May 16, 2011	Supplement 8Labeling	Approved	None posted
Sep 28, 2009	Supplement 6Labeling	Approved	None posted
Mar 20, 2009	Supplement 5Labeling	Approved	None posted
Jun 9, 2004	Supplement 15	Approved	Letter
Jun 9, 2004	Original application	Approved	Letter

Identifiers

Application: ANDA 76126
Drugs@FDA: Overview at FDA
Company: Carlsbad Technology

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