NDA 18084, held by Ortho Mcneil Janssen. Tolmetin Sodium.
As of Nov 13, 2026, NDA 18084 (Tolectin Ds), held by Ortho Mcneil Janssen, was first approved by FDA on Oct 30, 1979, with 38 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 29, 1988 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | None posted |
| Oct 30, 1979 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tolectin DsEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Tolmetin Sodium | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 22, 2008 | Supplement 52Labeling · Standard review | Approved | |
| Feb 9, 2006 | Supplement 51Labeling · Standard review | Approved | |
| Dec 19, 2000 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Aug 25, 2000 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Mar 4, 1996 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Mar 18, 1993 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Jan 21, 1993 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Oct 2, 1991 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Jul 11, 1991 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Mar 25, 1991 | Supplement 41Labeling · Standard review | Approved | None posted |
| Dec 18, 1989 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1989 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| May 30, 1989 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| May 30, 1989 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1988 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | None posted |
| Dec 2, 1987 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Jul 31, 1986 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Jul 31, 1986 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Dec 11, 1985 | Supplement 28Labeling · Standard review | Approved | None posted |
| Dec 11, 1985 | Supplement 27Labeling · Standard review | Approved | None posted |
| Dec 11, 1985 | Supplement 26Labeling · Standard review | Approved | None posted |
| Feb 7, 1985 | Supplement 25Labeling · Standard review | Approved | None posted |
| Jan 18, 1985 | Supplement 21Labeling · Standard review | Approved | None posted |
| Jan 18, 1985 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jan 15, 1985 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Jan 15, 1985 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Oct 5, 1984 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| May 3, 1984 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Jun 16, 1983 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| May 25, 1983 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Apr 6, 1983 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1983 | Supplement 18Labeling · Standard review | Approved | None posted |
| Jan 31, 1983 | Supplement 17Labeling · Standard review | Approved | None posted |
| Jul 27, 1982 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jul 12, 1982 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Dec 21, 1981 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jun 12, 1981 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Apr 1, 1981 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Oct 30, 1979 | 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
