Treats skin and skin structure infections caused by Escherichia coli, Klebsiella…. NDA 19537, held by Bayer Hlthcare. Ciprofloxacin Hydrochloride.
As of Nov 13, 2026, NDA 19537 (Cipro), held by Bayer Hlthcare, was first approved by FDA on Oct 22, 1987, with 55 approved supplements and 0 published complete response letters.
CIPRO is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 2, 2015 | Supplement 83Efficacy (new indication or use) · Standard review | Approved | None posted |
| Jan 7, 2005 | Supplement 52Efficacy (new indication or use) | Approved | None posted |
| Mar 25, 2004 | Supplement 49Efficacy (new indication or use) · Priority review | Approved | None posted |
| Aug 30, 2000 | Supplement 38Efficacy (new indication or use) · Priority review | Approved | None posted |
| Apr 3, 1998 | Supplement 27Efficacy (new indication or use) | Approved | None posted |
| Jun 3, 1997 | Supplement 29Efficacy (new indication or use) | Approved | None posted |
| May 15, 1997 | Supplement 16Efficacy (new indication or use) | Approved | None posted |
| Oct 10, 1996 | Supplement 22Efficacy (new indication or use) | Approved | None posted |
| Sep 11, 1996 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | None posted |
| Sep 13, 1995 | Supplement 19Efficacy (new indication or use) | Approved | None posted |
| Jul 21, 1994 | Supplement 15Efficacy (new indication or use) | Approved | None posted |
| Jul 21, 1994 | Supplement 13Efficacy (new indication or use) | Approved | None posted |
| Oct 22, 1987 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| CiproEQ 250MG BASE · tablet;oral | Ciprofloxacin Hydrochloride | RxReference drug |
| CiproEQ 500MG BASE · tablet;oral | Ciprofloxacin Hydrochloride | RxReference drug |
| CiproEQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Ciprofloxacin Hydrochloride | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 20, 2024 | Supplement 95Labeling · Standard review | Approved | |
| Nov 11, 2021 | Supplement 92Labeling · Standard review | Approved | None posted |
| Mar 30, 2021 | Supplement 93Labeling · Standard review | Approved | None posted |
| May 8, 2020 | Supplement 91Labeling · Standard review | Approved | None posted |
| Mar 5, 2020 | Supplement 90Labeling · Standard review | Approved | None posted |
| May 3, 2019 | Supplement 89Labeling · Standard review | Approved | None posted |
| Oct 18, 2018 | Supplement 88Labeling · Standard review | Approved | None posted |
| Jul 26, 2017 | Supplement 87Labeling · Standard review | Approved | None posted |
| Sep 14, 2016 | Supplement 85Labeling · Standard review | Approved | None posted |
| Jul 26, 2016 | Supplement 86Labeling · Standard review | Approved | None posted |
| Feb 2, 2015 | Supplement 83Efficacy (new indication or use) · Standard review | Approved | None posted |
| Aug 14, 2013 | Supplement 82Labeling | Approved | None posted |
| Jan 30, 2013 | Supplement 81Labeling · Standard review | Approved | None posted |
| Nov 15, 2011 | Supplement 74Labeling | Approved | None posted |
| Oct 18, 2011 | Supplement 80Labeling | Approved | None posted |
| Aug 3, 2011 | Supplement 79REMS | Approved | None posted |
| Jun 10, 2011 | Supplement 78Labeling | Approved | None posted |
| Feb 25, 2011 | Supplement 75Labeling | Approved | None posted |
| Jun 24, 2009 | Supplement 71Labeling · Standard review | Approved | None posted |
| Apr 27, 2009 | Supplement 70Labeling · Standard review | Approved | None posted |
| Apr 6, 2009 | Supplement 73Labeling · Standard review | Approved | None posted |
| Feb 13, 2009 | Supplement 69Labeling · Standard review | Approved | None posted |
| Oct 3, 2008 | Supplement 68Labeling · Standard review | Approved | None posted |
| Jan 18, 2008 | Supplement 67Labeling · Standard review | Approved | None posted |
| Jun 25, 2007 | Supplement 65Labeling · Standard review | Approved | None posted |
| Jun 19, 2006 | Supplement 62Labeling · Standard review | Approved | None posted |
| Nov 9, 2005 | Supplement 60Labeling · Standard review | Approved | None posted |
| May 18, 2005 | Supplement 57Labeling · Standard review | Approved | None posted |
| Jan 7, 2005 | Supplement 52Efficacy (new indication or use) | Approved | None posted |
| Jul 14, 2004 | Supplement 54Labeling · Standard review | Approved | None posted |
| Jul 14, 2004 | Supplement 53Labeling · Standard review | Approved | None posted |
| Mar 25, 2004 | Supplement 49Efficacy (new indication or use) · Priority review | Approved | None posted |
| Mar 15, 2004 | Supplement 51Labeling · Standard review | Approved | None posted |
| Mar 15, 2004 | Supplement 50Labeling · Standard review | Approved | None posted |
| Mar 15, 2004 | Supplement 48Labeling · Standard review | Approved | None posted |
| Apr 17, 2002 | Supplement 41Labeling · Standard review | Approved | None posted |
| Aug 30, 2000 | Supplement 38Efficacy (new indication or use) · Priority review | Approved | None posted |
| Jun 28, 2000 | Supplement 40Labeling · Standard review | Approved | None posted |
| Jun 28, 2000 | Supplement 39Labeling · Standard review | Approved | None posted |
| Jun 28, 2000 | Supplement 36Labeling · Standard review | Approved | None posted |
| Jun 28, 2000 | Supplement 34Labeling · Standard review | Approved | None posted |
| Sep 17, 1998 | Supplement 33Labeling · Standard review | Approved | None posted |
| Sep 17, 1998 | Supplement 31Labeling · Standard review | Approved | None posted |
| Sep 17, 1998 | Supplement 30Labeling · Standard review | Approved | None posted |
| Apr 3, 1998 | Supplement 27Efficacy (new indication or use) | Approved | None posted |
| Sep 26, 1997 | Supplement 25Labeling · Standard review | Approved | None posted |
| Jun 3, 1997 | Supplement 29Efficacy (new indication or use) | Approved | None posted |
| May 15, 1997 | Supplement 16Efficacy (new indication or use) | Approved | None posted |
| Nov 22, 1996 | Supplement 28Labeling · Standard review | Approved | None posted |
| Oct 10, 1996 | Supplement 22Efficacy (new indication or use) | Approved | None posted |
| Sep 11, 1996 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | None posted |
| Sep 13, 1995 | Supplement 19Efficacy (new indication or use) | Approved | None posted |
| Jul 21, 1994 | Supplement 15Efficacy (new indication or use) | Approved | None posted |
| Jul 21, 1994 | Supplement 13Efficacy (new indication or use) | Approved | None posted |
| Jan 22, 1993 | Supplement 8Labeling | Approved | None posted |
| Oct 22, 1987 | Original applicationNew molecular entity · Priority review | Approved | None posted |
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
