Ciprofloxacin In Dextrose 5%

ANDA 76757, held by Hikma Farmaceutica. Ciprofloxacin.

As of Nov 15, 2026, ANDA 76757 (Ciprofloxacin In Dextrose 5%), held by Hikma Farmaceutica, was first approved by FDA on Apr 21, 2008, with 9 approved supplements and 0 published complete response letters.

First approved: Apr 21, 2008
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Apr 21, 2008	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ciprofloxacin In Dextrose 5%200MG/100ML · injectable;injection	Ciprofloxacin	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Sep 20, 2024	Supplement 10Labeling · Standard review	Approved	None posted
May 3, 2019	Supplement 9Labeling · Standard review	Approved	None posted
Apr 18, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Oct 18, 2018	Supplement 7Labeling · Standard review	Approved	None posted
Oct 15, 2018	Supplement 5Labeling · Standard review	Approved	None posted
Oct 15, 2018	Supplement 6Labeling · Standard review	Approved	None posted
Jun 25, 2014	Supplement 3Labeling · Standard review	Approved	None posted
Jun 23, 2011	Supplement 2Labeling	Approved	None posted
Jul 9, 2009	Supplement 1Labeling	Approved	None posted
Apr 21, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 76757
Drugs@FDA: Overview at FDA
Company: Hikma Farmacêutica

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