NDA 19847, held by Bayer Hlthcare. Ciprofloxacin.
As of Nov 13, 2026, NDA 19847 (Cipro), held by Bayer Hlthcare, was first approved by FDA on Dec 26, 1990, with 52 approved supplements and 0 published complete response letters.
| Feb 2, 2015 | Supplement 55Efficacy (new indication or use) · Standard review | Approved | |
| Jan 7, 2005 | Supplement 30Efficacy (new indication or use) | Approved | |
| Mar 25, 2004 | Supplement 27Efficacy (new indication or use) · Priority review | Approved | |
| Aug 30, 2000 | Supplement 24Efficacy (new indication or use) · Priority review | Approved | |
| Sep 24, 1998 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | None posted |
| Sep 24, 1998 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | None posted |
| Apr 3, 1998 | Supplement 13Efficacy (new indication or use) | Approved | None posted |
| Aug 7, 1997 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | None posted |
| Oct 21, 1996 | Supplement 8Efficacy (new indication or use) | Approved | None posted |
| Oct 10, 1996 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | None posted |
| Dec 26, 1990 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Cipro400MG/40ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Ciprofloxacin | DiscontinuedReference drug |
| Cipro200MG/20ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Ciprofloxacin | DiscontinuedReference drug |
| Cipro1200MG/120ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Ciprofloxacin | Discontinued |
| Sep 20, 2024 | Supplement 64Labeling · Standard review | Approved | |
| Mar 25, 2022 | Supplement 63Labeling · Standard review | Approved | |
| May 8, 2020 | Supplement 62Labeling · Standard review | Approved | |
| Mar 5, 2020 | Supplement 61Labeling · Standard review | Approved | |
| May 3, 2019 | Supplement 60Labeling · Standard review | Approved | |
| Oct 18, 2018 | Supplement 59Labeling · Standard review | Approved | |
| Jul 28, 2017 | Supplement 58Labeling · Standard review | Approved | |
| Jul 26, 2016 | Supplement 57Labeling · Standard review | Approved | |
| Mar 19, 2015 | Supplement 56Labeling · Standard review | Approved | |
| Feb 2, 2015 | Supplement 55Efficacy (new indication or use) · Standard review | Approved | |
| Aug 14, 2013 | Supplement 54Labeling | Approved | |
| Jan 30, 2013 | Supplement 53Labeling · Standard review | Approved | |
| Nov 15, 2011 | Supplement 46Labeling · Standard review | Approved | |
| Oct 18, 2011 | Supplement 52Labeling | Approved | |
| Aug 12, 2011 | Supplement 50Labeling | Approved | |
| Aug 3, 2011 | Supplement 51REMS | Approved | |
| Feb 25, 2011 | Supplement 47Labeling | Approved | |
| Jun 24, 2009 | Supplement 45Labeling · Standard review | Approved | |
| Apr 27, 2009 | Supplement 44Labeling · Standard review | Approved | |
| Feb 13, 2009 | Supplement 43Labeling · Standard review | Approved | |
| Oct 3, 2008 | Supplement 42Labeling · Standard review | Approved | |
| Jan 18, 2008 | Supplement 41Labeling · Standard review | Approved | |
| Jun 25, 2007 | Supplement 39Labeling · Standard review | Approved | |
| Jun 19, 2006 | Supplement 37Labeling · Standard review | Approved | |
| Nov 9, 2005 | Supplement 36Labeling · Standard review | Approved | |
| May 18, 2005 | Supplement 32Labeling · Standard review | Approved | |
| Jan 7, 2005 | Supplement 30Efficacy (new indication or use) | Approved | |
| Jul 14, 2004 | Supplement 31Labeling · Standard review | Approved | |
| Jul 14, 2004 | Supplement 29Labeling · Standard review | Approved | |
| Jul 14, 2004 | Supplement 28Labeling · Standard review | Approved | |
| Mar 25, 2004 | Supplement 27Efficacy (new indication or use) · Priority review | Approved | |
| Apr 17, 2002 | Supplement 26Labeling | Approved | |
| Oct 31, 2000 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Aug 30, 2000 | Supplement 24Efficacy (new indication or use) · Priority review | Approved | |
| Jun 28, 2000 | Supplement 21Labeling · Standard review | Approved | None posted |
| Nov 1, 1999 | Supplement 22Manufacturing · Standard review | Approved | |
| Sep 24, 1998 | Supplement 20Labeling · Standard review | Approved | None posted |
| Sep 24, 1998 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | None posted |
| Sep 24, 1998 | Supplement 17Labeling · Standard review | Approved | None posted |
| Sep 24, 1998 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | None posted |
| Apr 3, 1998 | Supplement 13Efficacy (new indication or use) | Approved | None posted |
| Sep 26, 1997 | Supplement 12Labeling · Standard review | Approved | |
| Aug 7, 1997 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | None posted |
| Oct 21, 1996 | Supplement 8Efficacy (new indication or use) | Approved | None posted |
| Oct 10, 1996 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | None posted |
| Aug 9, 1996 | Supplement 14Labeling · Standard review | Approved | None posted |
| Oct 25, 1995 | Supplement 5Labeling | Approved | None posted |
| Jun 14, 1993 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Feb 12, 1993 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| May 13, 1992 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| May 13, 1992 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Apr 23, 1992 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Dec 26, 1990 | Original applicationNew dosage form · Standard 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
