Ciprofloxacin In Dextrose 5% In Plastic Container

ANDA 77753, held by Hospira. Ciprofloxacin.

As of Nov 15, 2026, ANDA 77753 (Ciprofloxacin In Dextrose 5% In Plastic Container), held by Hospira, 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

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 20, 2024	Supplement 25Labeling · Standard review	Approved	None posted
Apr 5, 2023	Supplement 23Labeling · Standard review	Approved	None posted
Apr 5, 2023	Supplement 22Labeling · Standard review	Approved	None posted
Apr 5, 2023	Supplement 21Labeling · Standard review	Approved	None posted
May 3, 2019	Supplement 20Labeling · Standard review	Approved	None posted
Oct 18, 2018	Supplement 19Labeling · Standard review	Approved	None posted
Oct 15, 2018	Supplement 18Labeling · Standard review	Approved	None posted
Oct 15, 2018	Supplement 15Labeling · Standard review	Approved	None posted
May 5, 2016	Supplement 14Labeling · Standard review	Approved	None posted
Jun 27, 2014	Supplement 13Labeling · Standard review	Approved	None posted
Mar 15, 2012	Supplement 11Labeling	Approved	None posted
Jul 26, 2011	Supplement 8Labeling	Approved	None posted
Sep 15, 2009	Supplement 5Labeling	Approved	None posted
Jun 19, 2009	Supplement 3Labeling	Approved	None posted
Jan 14, 2009	Supplement 2Labeling	Approved	None posted
Mar 18, 2008	Original application	Approved	Letter

Identifiers

Application: ANDA 77753
Drugs@FDA: Overview at FDA
Company: Hospira

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