NDA 19384, held by Merck. Norfloxacin.
As of Nov 13, 2026, NDA 19384 (Noroxin), held by Merck, was first approved by FDA on Oct 31, 1986, with 54 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 24, 1994 | Supplement 20Efficacy (new indication or use) | Approved | None posted |
| Nov 26, 1991 | Supplement 7Efficacy (new indication or use) | Approved | None posted |
| Nov 26, 1991 | Supplement 11Efficacy (new indication or use) | Approved | None posted |
| Oct 31, 1986 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Noroxin400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Norfloxacin | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 26, 2016 | Supplement 67Labeling · Standard review | Approved | |
| Aug 14, 2013 | Supplement 66Labeling · Standard review | Approved | |
| Mar 27, 2013 | Supplement 65Labeling · Standard review | Approved | |
| Jun 15, 2012 | Supplement 63Labeling · Standard review | Approved | |
| Feb 9, 2012 | Supplement 62Labeling · Standard review | Approved | |
| Oct 18, 2011 | Supplement 60Labeling | Approved | |
| Sep 16, 2011 | Supplement 61Labeling | Approved | |
| Sep 8, 2011 | Supplement 58Labeling | Approved | |
| Jun 10, 2011 | Supplement 55Labeling | Approved | |
| May 27, 2011 | Supplement 59Labeling | Approved | |
| Feb 25, 2011 | Supplement 56Labeling | Approved | |
| Apr 27, 2009 | Supplement 54Labeling · Standard review | Approved | |
| Feb 12, 2009 | Supplement 53Labeling · Standard review | Approved | |
| Oct 3, 2008 | Supplement 52Labeling · Standard review | Approved | |
| Sep 23, 2008 | Supplement 50Labeling · Priority review | Approved | |
| Sep 23, 2008 | Supplement 49Labeling · Standard review | Approved | |
| Mar 20, 2007 | Supplement 47Manufacturing | Approved | None posted |
| Mar 14, 2007 | Supplement 48Labeling · Standard review | Approved | |
| Sep 22, 2006 | Supplement 46Labeling · Standard review | Approved | |
| May 16, 2006 | Supplement 45Labeling · Standard review | Approved | |
| Jul 23, 2004 | Supplement 43Labeling · Standard review | Approved | |
| Jul 23, 2004 | Supplement 42Labeling · Standard review | Approved | |
| Jul 23, 2004 | Supplement 40Labeling · Standard review | Approved | |
| Apr 16, 2001 | Supplement 39Labeling · Standard review | Approved | |
| Apr 16, 2001 | Supplement 38Labeling · Standard review | Approved | |
| Apr 16, 2001 | Supplement 37Labeling · Standard review | Approved | |
| Feb 9, 1998 | Supplement 26Labeling · Standard review | Approved | None posted |
| Jun 20, 1997 | Supplement 36Labeling · Standard review | Approved | |
| Jan 15, 1997 | Supplement 31Labeling · Standard review | Approved | |
| Dec 6, 1996 | Supplement 35Manufacturing · Priority review | Approved | |
| Sep 12, 1996 | Supplement 29Labeling · Standard review | Approved | |
| Jul 18, 1996 | Supplement 34Manufacturing · Priority review | Approved | |
| Jul 18, 1996 | Supplement 30Manufacturing · Priority review | Approved | |
| Jun 18, 1996 | Supplement 32Manufacturing · Priority review | Approved | |
| Dec 26, 1995 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| Nov 29, 1995 | Supplement 27Labeling · Standard review | Approved | |
| Oct 24, 1994 | Supplement 20Efficacy (new indication or use) | Approved | None posted |
| Jul 1, 1994 | Supplement 24Labeling · Standard review | Approved | |
| Jun 29, 1993 | Supplement 21Labeling | Approved | None posted |
| May 6, 1992 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| Apr 17, 1992 | Supplement 16Labeling | Approved | None posted |
| Mar 6, 1992 | Supplement 18Labeling | Approved | None posted |
| Nov 26, 1991 | Supplement 7Efficacy (new indication or use) | Approved | None posted |
| Nov 26, 1991 | Supplement 9Labeling | Approved | None posted |
| Nov 26, 1991 | Supplement 11Efficacy (new indication or use) | Approved | None posted |
| Nov 26, 1991 | Supplement 12Labeling | Approved | None posted |
| Nov 26, 1991 | Supplement 13Labeling | Approved | None posted |
| Nov 26, 1991 | Supplement 14Labeling | Approved | None posted |
| Nov 26, 1991 | Supplement 15Labeling | Approved | None posted |
| Jun 28, 1988 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Jan 28, 1988 | Supplement 3Labeling | Approved | None posted |
| Jan 28, 1988 | Supplement 5Labeling | Approved | None posted |
| Jan 28, 1988 | Supplement 6Labeling | Approved | None posted |
| Mar 18, 1987 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Oct 31, 1986 | Original applicationNew molecular entity · Priority review | Approved |
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
