NDA 19735, held by Janssen Pharms. Ofloxacin.
As of Nov 13, 2026, NDA 19735 (Floxin), held by Janssen Pharms, was first approved by FDA on Dec 28, 1990, with 42 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 19, 1996 | Supplement 42Efficacy (new indication or use) · Standard review | Approved | None posted |
| Dec 28, 1990 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Floxin200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Ofloxacin | DiscontinuedReference drug |
| Floxin300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Ofloxacin | DiscontinuedReference drug |
| Floxin400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Ofloxacin | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 25, 2011 | Supplement 61Labeling · Standard review | Approved | |
| Feb 12, 2009 | Supplement 60Labeling · Standard review | Approved | |
| Oct 3, 2008 | Supplement 59Labeling · Standard review | Approved | |
| Dec 13, 2007 | Supplement 58Labeling · Standard review | Approved | |
| Jun 19, 2007 | Supplement 57Labeling · Standard review | Approved | |
| May 16, 2007 | Supplement 56Labeling · Standard review | Approved | |
| Jun 14, 2006 | Supplement 55Labeling · Standard review | Approved | |
| Jan 20, 2006 | Supplement 54Labeling · Standard review | Approved | |
| Sep 15, 2004 | Supplement 53Labeling · Standard review | Approved | |
| Sep 15, 2004 | Supplement 52Labeling · Standard review | Approved | |
| Mar 6, 2004 | Supplement 51Labeling · Standard review | Approved | |
| Oct 30, 2000 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Dec 8, 1999 | Supplement 49Labeling · Standard review | Approved | None posted |
| Dec 8, 1999 | Supplement 47Labeling · Standard review | Approved | None posted |
| Dec 8, 1999 | Supplement 45Labeling · Standard review | Approved | None posted |
| Sep 8, 1999 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Mar 25, 1999 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Sep 21, 1998 | Supplement 44Labeling · Standard review | Approved | None posted |
| Aug 11, 1997 | Supplement 39Labeling · Standard review | Approved | None posted |
| Dec 19, 1996 | Supplement 42Efficacy (new indication or use) · Standard review | Approved | None posted |
| Sep 11, 1996 | Supplement 38Labeling · Standard review | Approved | None posted |
| Jun 28, 1996 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Nov 9, 1995 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Sep 22, 1995 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Jan 9, 1995 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1994 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Jul 21, 1994 | Supplement 24Labeling · Standard review | Approved | None posted |
| Dec 7, 1993 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Nov 30, 1993 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Nov 30, 1993 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Nov 30, 1993 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Sep 20, 1993 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Aug 11, 1993 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Dec 8, 1992 | Supplement 18Manufacturing · Standard review | Approved | |
| Sep 10, 1992 | Supplement 19Manufacturing · Standard review | Approved | |
| Sep 3, 1992 | Supplement 23Manufacturing · Standard review | Approved | |
| Sep 3, 1992 | Supplement 22Manufacturing · Standard review | Approved | |
| Jul 14, 1992 | Supplement 16Manufacturing · Standard review | Approved | |
| Jun 23, 1992 | Supplement 8Manufacturing · Standard review | Approved | |
| May 15, 1992 | Supplement 7Manufacturing · Standard review | Approved | |
| Dec 13, 1991 | Supplement 4Manufacturing · Standard review | Approved | |
| Feb 28, 1991 | Supplement 1Manufacturing · Standard review | Approved | |
| Dec 28, 1990 | Original applicationNew molecular entity · 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
