NDA 50051, held by Wyeth Ayerst. Griseofulvin, Microcrystalline.
As of Nov 14, 2026, NDA 50051 (Grisactin), held by Wyeth Ayerst, was first approved by FDA on Aug 22, 1962, with 59 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 22, 1962 | Original application | Approved | None posted |
| Grisactin250MG · capsule;oral | Griseofulvin, Microcrystalline | Discontinued |
| Grisactin125MG · capsule;oral | Griseofulvin, Microcrystalline | Discontinued |
| May 9, 1996 | Supplement 65Manufacturing | Approved | None posted |
| Jan 28, 1993 | Supplement 5Manufacturing | Approved | None posted |
| Jul 29, 1987 | Supplement 4Manufacturing | Approved | None posted |
| Jan 12, 1984 | Supplement 2Manufacturing | Approved | None posted |
| Jun 29, 1983 | Supplement 1Manufacturing | Approved | None posted |
| May 26, 1981 | Supplement 64Manufacturing | Approved | None posted |
| May 20, 1981 | Supplement 63Manufacturing | Approved | None posted |
| Feb 19, 1981 | Supplement 62Manufacturing | Approved | None posted |
| Dec 31, 1980 | Supplement 61Manufacturing | Approved | None posted |
| Aug 27, 1980 | Supplement 60Manufacturing | Approved | None posted |
| Jun 24, 1980 | Supplement 59Manufacturing | Approved | None posted |
| Jan 21, 1980 | Supplement 58Manufacturing | Approved | None posted |
| Nov 8, 1979 | Supplement 56Manufacturing | Approved | None posted |
| Nov 8, 1979 | Supplement 57Manufacturing | Approved | None posted |
| Oct 18, 1978 | Supplement 55Manufacturing | Approved | None posted |
| Jun 21, 1977 | Supplement 54Manufacturing | Approved | None posted |
| Jun 10, 1977 | Supplement 53Manufacturing | Approved | None posted |
| Oct 29, 1976 | Supplement 52Manufacturing | Approved | None posted |
| May 13, 1976 | Supplement 50Manufacturing | Approved | None posted |
| Apr 1, 1976 | Supplement 49Manufacturing | Approved | None posted |
| Nov 11, 1975 | Supplement 48Manufacturing | Approved | None posted |
| Sep 30, 1975 | Supplement 47Manufacturing | Approved | None posted |
| Oct 16, 1974 | Supplement 51Manufacturing | Approved | None posted |
| Jun 5, 1974 | Supplement 46Manufacturing | Approved | None posted |
| May 22, 1974 | Supplement 45Manufacturing | Approved | None posted |
| Feb 22, 1974 | Supplement 44Manufacturing | Approved | None posted |
| Feb 12, 1973 | Supplement 43Manufacturing | Approved | None posted |
| Feb 2, 1973 | Supplement 42Manufacturing | Approved | None posted |
| Jun 20, 1972 | Supplement 37Manufacturing | Approved | None posted |
| Jun 16, 1972 | Supplement 41Labeling | Approved | None posted |
| May 3, 1972 | Supplement 40Labeling | Approved | None posted |
| Mar 27, 1972 | Supplement 39Manufacturing | Approved | None posted |
| Feb 3, 1972 | Supplement 38Manufacturing | Approved | None posted |
| Nov 12, 1971 | Supplement 35Labeling | Approved | None posted |
| Sep 13, 1971 | Supplement 34Labeling | Approved | None posted |
| Jun 28, 1971 | Supplement 33Labeling | Approved | None posted |
| Jun 3, 1971 | Supplement 32Manufacturing | Approved | None posted |
| Jul 29, 1969 | Supplement 31Manufacturing | Approved | None posted |
| Jul 15, 1969 | Supplement 29Manufacturing | Approved | None posted |
| Jul 15, 1969 | Supplement 30Manufacturing | Approved | None posted |
| Apr 24, 1969 | Supplement 28Manufacturing | Approved | None posted |
| Jul 27, 1967 | Supplement 27Labeling | Approved | None posted |
| Oct 28, 1966 | Supplement 25Manufacturing | Approved | None posted |
| Sep 27, 1966 | Supplement 24Manufacturing | Approved | None posted |
| May 16, 1966 | Supplement 23Manufacturing | Approved | None posted |
| May 2, 1966 | Supplement 20Labeling | Approved | None posted |
| May 2, 1966 | Supplement 21Labeling | Approved | None posted |
| Apr 29, 1966 | Supplement 22Labeling | Approved | None posted |
| Mar 18, 1966 | Supplement 19Labeling | Approved | None posted |
| Mar 15, 1966 | Supplement 18Manufacturing | Approved | None posted |
| Mar 14, 1966 | Supplement 17Manufacturing | Approved | None posted |
| Feb 7, 1966 | Supplement 16Labeling | Approved | None posted |
| Nov 2, 1965 | Supplement 15Labeling | Approved | None posted |
| Apr 26, 1965 | Supplement 14Manufacturing | Approved | None posted |
| Mar 16, 1965 | Supplement 9Labeling | Approved | None posted |
| Nov 24, 1964 | Supplement 13Manufacturing | Approved | None posted |
| Sep 21, 1964 | Supplement 11Labeling | Approved | None posted |
| Aug 4, 1964 | Supplement 7Labeling | Approved | None posted |
| Jun 24, 1964 | Supplement 10Manufacturing | Approved | None posted |
| Aug 22, 1962 | Original application | 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
