NDA 11011, held by Endo Operations. Methocarbamol.
As of Nov 13, 2026, NDA 11011 (Robaxin, Robaxin-750), held by Endo Operations, was first approved by FDA on Jul 16, 1957, with 42 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 16, 1957 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Robaxin500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Methocarbamol | DiscontinuedReference drug |
| Robaxin-750750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Methocarbamol | DiscontinuedReference drug |
| Mar 1, 2019 | Supplement 79Labeling · Standard review | Approved | |
| Mar 9, 2015 | Supplement 77Manufacturing · Standard review | Approved | None posted |
| May 1, 2003 | Supplement 70Labeling · Standard review | Approved | |
| May 1, 2003 | Supplement 71Labeling · Standard review | Approved | |
| Apr 22, 1998 | Supplement 69Manufacturing · Standard review | Approved | None posted |
| Aug 21, 1990 | Supplement 66Manufacturing · Standard review | Approved | None posted |
| Jan 6, 1989 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| Jan 28, 1987 | Supplement 63Manufacturing · Standard review | Approved | None posted |
| Apr 16, 1986 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Apr 16, 1986 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Oct 25, 1985 | Supplement 60Labeling | Approved | None posted |
| Apr 29, 1985 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1985 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Jun 27, 1984 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Apr 7, 1983 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Jan 25, 1983 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Oct 18, 1982 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Oct 1, 1982 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Jul 15, 1982 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Mar 15, 1982 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Jan 18, 1982 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Jan 18, 1982 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Dec 24, 1981 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Dec 24, 1981 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Dec 21, 1981 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1981 | Supplement 39Labeling | Approved | None posted |
| Nov 2, 1981 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Oct 28, 1981 | Supplement 38Labeling | Approved | None posted |
| Jan 22, 1981 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Jan 22, 1981 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Feb 11, 1980 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Jul 24, 1979 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| May 21, 1979 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| May 21, 1979 | Supplement 20Labeling | Approved | None posted |
| May 21, 1979 | Supplement 19Labeling | Approved | None posted |
| Mar 10, 1976 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| May 1, 1975 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1975 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1975 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Dec 9, 1974 | Supplement 11Labeling | Approved | None posted |
| Oct 22, 1974 | Supplement 15Labeling | Approved | None posted |
| Oct 17, 1974 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jul 16, 1957 | 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
