Ciprofloxacin Hydrochloride

ANDA 75593, held by Dr Reddys Labs Ltd. Ciprofloxacin Hydrochloride.

As of Nov 15, 2026, ANDA 75593 (Ciprofloxacin Hydrochloride), held by Dr Reddys Labs Ltd, was first approved by FDA on Jun 9, 2004, with 16 approved supplements and 0 published complete response letters.

First approved: Jun 9, 2004
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Jun 9, 2004	Original application	Approved	None posted

Products

3 strengths and forms


Ciprofloxacin HydrochlorideEQ 750MG BASE · tablet;oral	Ciprofloxacin Hydrochloride	Rx
Ciprofloxacin HydrochlorideEQ 250MG BASE · tablet;oral	Ciprofloxacin Hydrochloride	Rx
Ciprofloxacin HydrochlorideEQ 500MG BASE · tablet;oral	Ciprofloxacin Hydrochloride	Rx

All 17 submissions, including labeling and manufacturing supplements


Sep 28, 2015	Supplement 21Labeling · Standard review	Approved	None posted
Sep 28, 2015	Supplement 20Labeling · Standard review	Approved	None posted
Mar 27, 2013	Supplement 19Labeling · Standard review	Approved	None posted
Oct 12, 2012	Supplement 18Labeling	Approved	None posted
Feb 27, 2012	Supplement 16Labeling	Approved	None posted
Jan 11, 2012	Supplement 15Labeling	Approved	None posted
Nov 22, 2011	Supplement 14Labeling	Approved	None posted
May 8, 2011	Supplement 12Labeling	Approved	None posted
Apr 30, 2010	Supplement 10Labeling	Approved	None posted
May 20, 2009	Supplement 9Labeling	Approved	None posted
Dec 19, 2008	Supplement 8Labeling	Approved	None posted
May 13, 2008	Supplement 6Labeling	Approved	None posted
Jan 16, 2008	Supplement 5Labeling	Approved	None posted
Oct 5, 2007	Supplement 4Labeling	Approved	None posted
Feb 21, 2007	Supplement 2Labeling	Approved	None posted
Oct 5, 2006	Supplement 3Labeling	Approved	None posted
Jun 9, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 75593
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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