NDA 19857, held by Bayer Hlthcare. Ciprofloxacin.
As of Nov 13, 2026, NDA 19857 (Cipro In Dextrose 5% In Plastic Container), held by Bayer Hlthcare, was first approved by FDA on Dec 26, 1990, with 57 approved supplements and 0 published complete response letters.
| Feb 2, 2015 | Supplement 63Efficacy (new indication or use) · Standard review | Approved | |
| Jan 7, 2005 | Supplement 35Efficacy (new indication or use) | Approved | |
| Mar 25, 2004 | Supplement 31Efficacy (new indication or use) · Priority review | Approved | |
| Aug 30, 2000 | Supplement 27Efficacy (new indication or use) · Priority review | Approved | |
| Sep 24, 1998 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | None posted |
| Sep 24, 1998 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | None posted |
| Apr 3, 1998 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | None posted |
| Aug 7, 1997 | Supplement 17Efficacy (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 11Efficacy (new indication or use) | Approved | None posted |
| Dec 26, 1990 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Cipro In Dextrose 5% In Plastic Container200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Ciprofloxacin | DiscontinuedReference drug |
| Cipro In Dextrose 5% In Plastic Container400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Ciprofloxacin | DiscontinuedReference drug |
| Mar 25, 2022 | Supplement 73Labeling · Standard review | Approved | |
| May 8, 2020 | Supplement 72Labeling · Standard review | Approved | |
| Mar 5, 2020 | Supplement 70Labeling · Standard review | Approved | |
| May 3, 2019 | Supplement 69Labeling · Standard review | Approved | |
| Oct 18, 2018 | Supplement 68Labeling · Standard review | Approved | |
| Jul 26, 2017 | Supplement 66Labeling · Standard review | Approved | |
| Jul 26, 2016 | Supplement 65Labeling · Standard review | Approved | |
| Mar 19, 2015 | Supplement 64Labeling · Standard review | Approved | |
| Feb 2, 2015 | Supplement 63Efficacy (new indication or use) · Standard review | Approved | |
| Oct 14, 2013 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Aug 14, 2013 | Supplement 62Labeling | Approved | |
| Jan 30, 2013 | Supplement 60Labeling · Standard review | Approved | |
| Nov 15, 2011 | Supplement 53Labeling · Standard review | Approved | |
| Oct 18, 2011 | Supplement 59Labeling | Approved | |
| Aug 12, 2011 | Supplement 57Labeling · Standard review | Approved | |
| Aug 3, 2011 | Supplement 58REMS | Approved | |
| Feb 25, 2011 | Supplement 54Labeling | Approved | |
| Jun 24, 2009 | Supplement 52Labeling · Standard review | Approved | |
| Apr 27, 2009 | Supplement 51Labeling · Standard review | Approved | |
| Feb 13, 2009 | Supplement 50Labeling · Standard review | Approved | |
| Oct 3, 2008 | Supplement 49Labeling · Standard review | Approved | |
| Jan 18, 2008 | Supplement 48Labeling · Standard review | Approved | |
| Jun 25, 2007 | Supplement 46Labeling · Standard review | Approved | |
| Jun 19, 2006 | Supplement 42Labeling · Standard review | Approved | |
| Nov 9, 2005 | Supplement 41Labeling · Standard review | Approved | |
| May 18, 2005 | Supplement 38Labeling · Standard review | Approved | |
| Jan 7, 2005 | Supplement 35Efficacy (new indication or use) | Approved | |
| Jul 14, 2004 | Supplement 34Labeling · Standard review | Approved | |
| Jul 14, 2004 | Supplement 36Labeling · Standard review | Approved | |
| Jul 14, 2004 | Supplement 33Labeling · Standard review | Approved | |
| Mar 25, 2004 | Supplement 31Efficacy (new indication or use) · Priority review | Approved | |
| Dec 10, 2002 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Apr 17, 2002 | Supplement 28Labeling | Approved | |
| Aug 30, 2000 | Supplement 27Efficacy (new indication or use) · Priority review | Approved | |
| Jun 28, 2000 | Supplement 25Labeling · Standard review | Approved | None posted |
| Jun 9, 1999 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Jan 7, 1999 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Nov 13, 1998 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Sep 24, 1998 | Supplement 24Labeling · Standard review | Approved | None posted |
| Sep 24, 1998 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | None posted |
| Sep 24, 1998 | Supplement 20Labeling · Standard review | Approved | None posted |
| Sep 24, 1998 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | None posted |
| Apr 3, 1998 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | None posted |
| Sep 26, 1997 | Supplement 13Labeling · Standard review | Approved | |
| Aug 15, 1997 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Aug 7, 1997 | Supplement 17Efficacy (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 11Efficacy (new indication or use) | Approved | None posted |
| Aug 9, 1996 | Supplement 16Labeling · Standard review | Approved | None posted |
| Jun 28, 1996 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Oct 25, 1995 | Supplement 6Labeling | Approved | None posted |
| Apr 28, 1994 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Dec 27, 1993 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| May 13, 1992 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Apr 23, 1992 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Apr 24, 1991 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Apr 24, 1991 | Supplement 1Manufacturing · 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
