Ciprofloxacin

ANDA 77245, held by Hospira. Ciprofloxacin.

As of Nov 15, 2026, ANDA 77245 (Ciprofloxacin), held by Hospira, was first approved by FDA on Aug 28, 2006, with 12 approved supplements and 0 published complete response letters.

First approved: Aug 28, 2006
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Aug 28, 2006	Original application	Approved	Letter

Products

2 strengths and forms


Ciprofloxacin200MG/20ML (10MG/ML) · injectable;injection	Ciprofloxacin	Discontinued
Ciprofloxacin400MG/40ML (10MG/ML) · injectable;injection	Ciprofloxacin	Discontinued

All 13 submissions, including labeling and manufacturing supplements


May 3, 2019	Supplement 23Labeling · Standard review	Approved	None posted
Oct 18, 2018	Supplement 22Labeling · Standard review	Approved	None posted
Oct 15, 2018	Supplement 21Labeling · Standard review	Approved	None posted
Oct 15, 2018	Supplement 19Labeling · Standard review	Approved	None posted
May 5, 2016	Supplement 17Labeling · Standard review	Approved	None posted
Jun 27, 2014	Supplement 16Labeling · Standard review	Approved	None posted
Mar 8, 2012	Supplement 15Labeling	Approved	None posted
Jun 23, 2011	Supplement 13Labeling	Approved	None posted
Jun 19, 2009	Supplement 10Labeling	Approved	None posted
Jan 14, 2009	Supplement 8Labeling	Approved	None posted
Jul 22, 2008	Supplement 6Labeling	Approved	None posted
Oct 5, 2007	Supplement 4Labeling	Approved	None posted
Aug 28, 2006	Original application	Approved	Letter

Identifiers

Application: ANDA 77245
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