Ciprofloxacin In Dextrose 5% In Plastic Container

Treats skin and skin structure infections caused by Escherichia coli, Klebsiella…. ANDA 78252, held by Inforlife. Ciprofloxacin.

As of Nov 15, 2026, ANDA 78252 (Ciprofloxacin In Dextrose 5% In Plastic Container), held by Inforlife, was first approved by FDA on Mar 18, 2008, with 15 approved supplements and 0 published complete response letters.

First approved: Mar 18, 2008
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Ciprofloxacin Injection is 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 Nosocomial Pneumonia Empirical Therapy for Febrile Neutropenic Patients 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) Complicated UTI and Pyelonephritis in Pediatri…

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Mar 18, 2008	Original application	Approved	Letter

Products

2 strengths and forms


Ciprofloxacin In Dextrose 5% In Plastic Container200MG/100ML · injectable;injection	Ciprofloxacin	Rx
Ciprofloxacin In Dextrose 5% In Plastic Container400MG/200ML · injectable;injection	Ciprofloxacin	Rx

All 16 submissions, including labeling and manufacturing supplements


Sep 26, 2024	Supplement 40Labeling · Standard review	Approved	None posted
Sep 23, 2024	Supplement 38Labeling · Standard review	Approved	None posted
Sep 23, 2024	Supplement 33Labeling · Standard review	Approved	None posted
May 3, 2019	Supplement 32Labeling · Standard review	Approved	None posted
Apr 16, 2019	Supplement 31Labeling · Standard review	Approved	None posted
Apr 16, 2019	Supplement 30Labeling · Standard review	Approved	None posted
Oct 18, 2018	Supplement 29Labeling · Standard review	Approved	None posted
Jun 23, 2016	Supplement 22Labeling · Standard review	Approved	None posted
Apr 28, 2014	Supplement 16Labeling · Standard review	Approved	None posted
Jun 17, 2013	Supplement 13Labeling · Standard review	Approved	None posted
Mar 13, 2012	Supplement 10Labeling	Approved	None posted
Jun 23, 2011	Supplement 7Labeling	Approved	None posted
Oct 5, 2009	Supplement 5Labeling	Approved	None posted
Jun 19, 2009	Supplement 4Labeling	Approved	None posted
Dec 19, 2008	Supplement 1Labeling	Approved	None posted
Mar 18, 2008	Original application	Approved	Letter

Identifiers

Application: ANDA 78252
Drugs@FDA: Overview at FDA
Company: Inforlife

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