Ciprofloxacin In Dextrose 5% In Plastic Container

ANDA 78431, held by Hikma Farmaceutica. Ciprofloxacin.

As of Nov 15, 2026, ANDA 78431 (Ciprofloxacin In Dextrose 5% In Plastic Container), held by Hikma Farmaceutica, was first approved by FDA on Nov 18, 2009, with 8 approved supplements and 0 published complete response letters.

First approved: Nov 18, 2009
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Nov 18, 2009	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ciprofloxacin In Dextrose 5% In Plastic Container400MG/200ML · injectable;injection	Ciprofloxacin	Rx

All 9 submissions, including labeling and manufacturing supplements


Sep 20, 2024	Supplement 11Labeling · Standard review	Approved	None posted
May 3, 2019	Supplement 10Labeling · Standard review	Approved	None posted
Apr 16, 2019	Supplement 9Labeling · Standard review	Approved	None posted
Oct 18, 2018	Supplement 8Labeling · Standard review	Approved	None posted
Oct 15, 2018	Supplement 6Labeling · Standard review	Approved	None posted
Oct 15, 2018	Supplement 7Labeling · Standard review	Approved	None posted
Jun 25, 2014	Supplement 4Labeling · Standard review	Approved	None posted
Jul 7, 2011	Supplement 1Labeling	Approved	None posted
Nov 18, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78431
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