Ciprofloxacin

ANDA 76717, held by Hikma Farmaceutica. Ciprofloxacin.

As of Nov 15, 2026, ANDA 76717 (Ciprofloxacin), held by Hikma Farmaceutica, was first approved by FDA on Dec 22, 2009, with 8 approved supplements and 0 published complete response letters.

First approved: Dec 22, 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
Dec 22, 2009	Original application	Approved	None posted

Products

2 strengths and forms


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

All 9 submissions, including labeling and manufacturing supplements


Sep 20, 2024	Supplement 8Labeling · Standard review	Approved	None posted
May 3, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Apr 16, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Oct 18, 2018	Supplement 5Labeling · Standard review	Approved	None posted
Oct 15, 2018	Supplement 4Labeling · Standard review	Approved	None posted
Oct 15, 2018	Supplement 3Labeling · Standard review	Approved	None posted
Jun 25, 2014	Supplement 2Labeling · Standard review	Approved	None posted
Jun 23, 2011	Supplement 1Labeling	Approved	None posted
Dec 22, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 76717
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