NDA 17628, held by Ortho Mcneil Janssen. Tolmetin Sodium.
As of Nov 13, 2026, NDA 17628 (Tolectin, Tolectin 600), held by Ortho Mcneil Janssen, was first approved by FDA on Mar 24, 1976, with 51 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 8, 1989 | Supplement 31Efficacy (new indication or use) · Standard review | Approved | None posted |
| Apr 29, 1988 | Supplement 24Efficacy (new indication or use) · Standard review | Approved | None posted |
| Apr 6, 1979 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | None posted |
| Feb 21, 1978 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | None posted |
| Mar 24, 1976 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| TolectinEQ 200MG BASE · tablet;oral | Tolmetin Sodium | DiscontinuedReference drug |
| Tolectin 600EQ 600MG BASE · tablet;oral | Tolmetin Sodium | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 22, 2008 | Supplement 68Labeling · Standard review | Approved | |
| Feb 9, 2006 | Supplement 67Labeling · Standard review | Approved | |
| Mar 21, 2001 | Supplement 65Manufacturing · Standard review | Approved | None posted |
| Feb 26, 2001 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| Mar 4, 1996 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Jun 11, 1993 | Supplement 60Manufacturing · Standard review | Approved | None posted |
| Jan 21, 1993 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Oct 2, 1992 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| Jan 21, 1992 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Jul 11, 1991 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Mar 25, 1991 | Supplement 57Labeling · Standard review | Approved | None posted |
| Aug 17, 1990 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Dec 18, 1989 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1989 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Jul 28, 1989 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| May 30, 1989 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| May 30, 1989 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Mar 8, 1989 | Supplement 31Efficacy (new indication or use) · Standard review | Approved | None posted |
| Oct 19, 1988 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1988 | Supplement 24Efficacy (new indication or use) · Standard review | Approved | None posted |
| Dec 2, 1987 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Jul 31, 1986 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Jul 31, 1986 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Dec 11, 1985 | Supplement 38Labeling · Standard review | Approved | None posted |
| Dec 11, 1985 | Supplement 39Labeling · Standard review | Approved | None posted |
| Dec 11, 1985 | Supplement 40Labeling · Standard review | Approved | None posted |
| Feb 7, 1985 | Supplement 36Labeling · Standard review | Approved | None posted |
| Jan 18, 1985 | Supplement 33Labeling · Standard review | Approved | None posted |
| Jan 18, 1985 | Supplement 27Labeling · Standard review | Approved | None posted |
| Jan 18, 1985 | Supplement 19Labeling · Standard review | Approved | None posted |
| Jan 18, 1985 | Supplement 12Labeling · Standard review | Approved | None posted |
| Dec 11, 1984 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Oct 5, 1984 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| May 3, 1984 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Jun 16, 1983 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| May 25, 1983 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1983 | Supplement 29Labeling · Standard review | Approved | None posted |
| Jan 31, 1983 | Supplement 28Labeling · Standard review | Approved | None posted |
| Jul 27, 1982 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Jul 22, 1982 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jul 12, 1982 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Nov 22, 1981 | Supplement 11Labeling · Standard review | Approved | None posted |
| Mar 30, 1981 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Sep 19, 1980 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| May 15, 1979 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Apr 6, 1979 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | None posted |
| Mar 13, 1979 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Feb 21, 1978 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | None posted |
| Jul 23, 1976 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jul 23, 1976 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jun 28, 1976 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Mar 24, 1976 | 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
