Cipro Xr

NDA 21473, held by Bayer Hlthcare. Ciprofloxacin; Ciprofloxacin Hydrochloride.

As of Nov 14, 2026, NDA 21473 (Cipro Xr), held by Bayer Hlthcare, was first approved by FDA on Dec 13, 2002, with 26 approved supplements and 0 published complete response letters.

First approved: Dec 13, 2002
Review: Standard
Supplements approved: 26
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below

Date	Submission	Status	Documents
Dec 13, 2002	Original applicationNew dosage form · Standard review	Approved	Other Review Label Letter

Products

2 strengths and forms


Cipro Xr212.6MG;EQ 287.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Ciprofloxacin; Ciprofloxacin Hydrochloride	Discontinued
Cipro Xr425.2MG;EQ 574.9MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Ciprofloxacin; Ciprofloxacin Hydrochloride	Discontinued

All 27 submissions, including labeling and manufacturing supplements


Mar 30, 2021	Supplement 43Labeling · Standard review	Approved	Label Medication Guide Letter
May 8, 2020	Supplement 42Labeling · Standard review	Approved	Letter Label
Mar 5, 2020	Supplement 41Labeling · Standard review	Approved	Letter Label
May 3, 2019	Supplement 40Labeling · Standard review	Approved	Label Letter
Oct 18, 2018	Supplement 39Labeling · Standard review	Approved	Letter Label
Jul 26, 2017	Supplement 38Labeling · Standard review	Approved	Letter Label
Jul 26, 2016	Supplement 37Labeling · Standard review	Approved	Letter Label
Jan 30, 2015	Supplement 36Labeling · Standard review	Approved	Label Letter
Aug 14, 2013	Supplement 35Labeling	Approved	Letter Label
Jan 30, 2013	Supplement 34Labeling · Standard review	Approved	Label Letter
Nov 15, 2011	Supplement 27Labeling · Standard review	Approved	Letter Label
Oct 18, 2011	Supplement 33Labeling	Approved	Label Letter
Aug 3, 2011	Supplement 32REMS	Approved	Letter
Jun 10, 2011	Supplement 31Labeling · Standard review	Approved	Letter Label
Feb 25, 2011	Supplement 28Labeling	Approved	Label Letter
Jun 24, 2009	Supplement 26Labeling · Standard review	Approved	Letter
Apr 27, 2009	Supplement 25Labeling · Standard review	Approved	Label Letter
Oct 3, 2008	Supplement 24Labeling · Standard review	Approved	Label Letter
Jan 18, 2008	Supplement 23Labeling · Standard review	Approved	Letter Label
Jun 25, 2007	Supplement 22Labeling · Standard review	Approved	Letter Label
Jun 19, 2006	Supplement 16Labeling · Standard review	Approved	None posted
Nov 9, 2005	Supplement 13Labeling · Standard review	Approved	Review Letter Label
May 18, 2005	Supplement 9Labeling · Standard review	Approved	Review Letter Label
Jul 14, 2004	Supplement 7Labeling · Standard review	Approved	Review Letter Label
Jul 14, 2004	Supplement 6Labeling · Standard review	Approved	Review Letter Label
Jul 14, 2004	Supplement 5Labeling · Standard review	Approved	Review Letter Label
Dec 13, 2002	Original applicationNew dosage form · Standard review	Approved	Other Review Label Letter

Identifiers

Application: NDA 21473
Drugs@FDA: Overview at FDA
Company: Bayer Healthcare

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