NDA 50315, held by Triax Pharms. Minocycline Hydrochloride.
As of Nov 13, 2026, NDA 50315 (Minocin), held by Triax Pharms, was first approved by FDA on Jun 30, 1971, with 57 approved supplements and 0 published complete response letters.
| Jul 27, 1987 | Supplement 75Efficacy (new indication or use) | Approved | None posted |
| Sep 25, 1979 | Supplement 54Efficacy (new indication or use) | Approved | None posted |
| Nov 6, 1978 | Supplement 49Efficacy (new indication or use) | Approved | None posted |
| Jun 30, 1971 | Original application | Approved | None posted |
| MinocinEQ 100MG BASE · capsule;oral | Minocycline Hydrochloride | Discontinued |
| MinocinEQ 50MG BASE · capsule;oral | Minocycline Hydrochloride | Discontinued |
| Mar 30, 1989 | Supplement 76Labeling | Approved | None posted |
| Jul 27, 1987 | Supplement 75Efficacy (new indication or use) | Approved | None posted |
| May 1, 1987 | Supplement 74Labeling | Approved | None posted |
| Dec 2, 1986 | Supplement 73Manufacturing | Approved | None posted |
| Oct 29, 1986 | Supplement 69Labeling | Approved | None posted |
| Aug 19, 1986 | Supplement 72Manufacturing | Approved | None posted |
| May 23, 1986 | Supplement 71Manufacturing | Approved | None posted |
| Dec 3, 1985 | Supplement 70Manufacturing | Approved | None posted |
| Nov 30, 1984 | Supplement 66Manufacturing | Approved | None posted |
| Aug 15, 1983 | Supplement 65Labeling | Approved | None posted |
| Feb 28, 1983 | Supplement 63Manufacturing | Approved | None posted |
| Dec 14, 1982 | Supplement 62Manufacturing | Approved | None posted |
| Mar 22, 1982 | Supplement 61Manufacturing | Approved | None posted |
| Apr 29, 1981 | Supplement 55Labeling | Approved | None posted |
| Apr 29, 1981 | Supplement 58Manufacturing | Approved | None posted |
| Apr 4, 1980 | Supplement 57Manufacturing | Approved | None posted |
| Sep 25, 1979 | Supplement 54Efficacy (new indication or use) | Approved | None posted |
| May 15, 1979 | Supplement 53Manufacturing | Approved | None posted |
| Mar 30, 1979 | Supplement 52Manufacturing | Approved | None posted |
| Mar 26, 1979 | Supplement 51Manufacturing | Approved | None posted |
| Dec 26, 1978 | Supplement 50Manufacturing | Approved | None posted |
| Nov 6, 1978 | Supplement 49Efficacy (new indication or use) | Approved | None posted |
| Jul 9, 1978 | Supplement 48Manufacturing | Approved | None posted |
| May 22, 1978 | Supplement 47Manufacturing | Approved | None posted |
| Apr 28, 1978 | Supplement 45Manufacturing | Approved | None posted |
| Apr 28, 1978 | Supplement 46Manufacturing | Approved | None posted |
| Sep 30, 1977 | Supplement 44Manufacturing | Approved | None posted |
| Feb 14, 1977 | Supplement 35Manufacturing | Approved | None posted |
| Dec 8, 1976 | Supplement 42Manufacturing | Approved | None posted |
| Sep 24, 1976 | Supplement 39Manufacturing | Approved | None posted |
| Aug 25, 1976 | Supplement 41Manufacturing | Approved | None posted |
| Jun 28, 1976 | Supplement 40Manufacturing | Approved | None posted |
| Mar 4, 1976 | Supplement 37Manufacturing | Approved | None posted |
| Jul 7, 1975 | Supplement 34Labeling | Approved | None posted |
| May 21, 1975 | Supplement 33Manufacturing | Approved | None posted |
| May 7, 1975 | Supplement 32Labeling | Approved | None posted |
| Nov 4, 1974 | Supplement 31Labeling | Approved | None posted |
| Oct 24, 1974 | Supplement 30Labeling | Approved | None posted |
| Sep 23, 1974 | Supplement 29Labeling | Approved | None posted |
| Jun 19, 1974 | Supplement 28Manufacturing | Approved | None posted |
| Oct 10, 1973 | Supplement 27Manufacturing | Approved | None posted |
| Aug 31, 1973 | Supplement 26Labeling | Approved | None posted |
| Jul 2, 1973 | Supplement 22Manufacturing | Approved | None posted |
| Jul 2, 1973 | Supplement 23Manufacturing | Approved | None posted |
| Jun 22, 1973 | Supplement 24Labeling | Approved | None posted |
| Apr 27, 1973 | Supplement 21Labeling | Approved | None posted |
| Apr 6, 1973 | Supplement 20Labeling | Approved | None posted |
| Feb 2, 1973 | Supplement 14Manufacturing | Approved | None posted |
| Nov 24, 1972 | Supplement 13Manufacturing | Approved | None posted |
| Nov 20, 1972 | Supplement 9Manufacturing | Approved | None posted |
| Nov 20, 1972 | Supplement 10Manufacturing | Approved | None posted |
| Sep 20, 1972 | Supplement 12Labeling | Approved | None posted |
| May 1, 1972 | Supplement 7Manufacturing | Approved | None posted |
| Oct 13, 1971 | Supplement 6Labeling | Approved | None posted |
| Sep 28, 1971 | Supplement 4Manufacturing | Approved | None posted |
| Aug 16, 1971 | Supplement 1Labeling | Approved | None posted |
| Aug 11, 1971 | Supplement 3Labeling | Approved | None posted |
| Jun 30, 1971 | 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
