Ciprofloxacin Hydrochloride

ANDA 75685, held by Natco. Ciprofloxacin Hydrochloride.

As of Nov 15, 2026, ANDA 75685 (Ciprofloxacin Hydrochloride), held by Natco, was first approved by FDA on Jun 9, 2004, with 12 approved supplements and 0 published complete response letters.

First approved: Jun 9, 2004
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
Jun 9, 2004	Original application	Approved	Letter

Products

3 strengths and forms


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

All 13 submissions, including labeling and manufacturing supplements


Jul 21, 2025	Supplement 20Labeling · Standard review	Approved	None posted
Jul 21, 2025	Supplement 19Labeling · Standard review	Approved	None posted
Jul 21, 2025	Supplement 16Labeling · Standard review	Approved	None posted
Jul 21, 2025	Supplement 14Labeling · Standard review	Approved	None posted
Nov 17, 2015	Supplement 13Labeling · Standard review	Approved	None posted
Nov 17, 2015	Supplement 12Labeling · Standard review	Approved	None posted
Mar 5, 2012	Supplement 11Labeling	Approved	None posted
May 8, 2011	Supplement 10Labeling	Approved	None posted
May 10, 2010	Supplement 8Labeling	Approved	None posted
Jul 22, 2009	Supplement 7Labeling	Approved	None posted
Jan 29, 2009	Supplement 6Labeling	Approved	None posted
Apr 14, 2005	Supplement 1Labeling	Approved	None posted
Jun 9, 2004	Original application	Approved	Letter

Identifiers

Application: ANDA 75685
Drugs@FDA: Overview at FDA
Company: Natco Corp.

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