NDA 50261, held by Corepharma. Demeclocycline Hydrochloride.
As of Nov 13, 2026, NDA 50261 (Declomycin), held by Corepharma, was first approved by FDA on Sep 22, 1964, with 87 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 23, 1965 | Supplement 19Efficacy (new indication or use) | Approved | None posted |
| Sep 22, 1964 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Declomycin75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Demeclocycline Hydrochloride | Discontinued |
| Declomycin150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Demeclocycline Hydrochloride | Discontinued |
| Declomycin300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Demeclocycline Hydrochloride | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 5, 2012 | Supplement 101Labeling | Approved | |
| Apr 22, 2008 | Supplement 100Labeling | Approved | |
| Dec 18, 2003 | Supplement 94Labeling | Approved | |
| Dec 18, 2003 | Supplement 97Labeling | Approved | |
| May 1, 2003 | Supplement 95Labeling | Approved | |
| Dec 7, 2000 | Supplement 93Manufacturing | Approved | None posted |
| Oct 20, 1999 | Supplement 92Manufacturing | Approved | None posted |
| Jun 25, 1997 | Supplement 90Manufacturing | Approved | None posted |
| Jun 25, 1997 | Supplement 91Manufacturing | Approved | None posted |
| Nov 20, 1991 | Supplement 11Labeling | Approved | None posted |
| Dec 17, 1987 | Supplement 6Manufacturing | Approved | None posted |
| Oct 9, 1986 | Supplement 5Labeling | Approved | None posted |
| Jun 21, 1983 | Supplement 2Manufacturing | Approved | None posted |
| Mar 26, 1982 | Supplement 89Manufacturing | Approved | None posted |
| Apr 8, 1980 | Supplement 88Manufacturing | Approved | None posted |
| May 16, 1979 | Supplement 87Manufacturing | Approved | None posted |
| Sep 20, 1978 | Supplement 86Manufacturing | Approved | None posted |
| Sep 14, 1978 | Supplement 85Manufacturing | Approved | None posted |
| Jun 7, 1978 | Supplement 84Labeling | Approved | None posted |
| Aug 25, 1976 | Supplement 83Manufacturing | Approved | None posted |
| Jun 25, 1976 | Supplement 82Manufacturing | Approved | None posted |
| Mar 22, 1976 | Supplement 81Manufacturing | Approved | None posted |
| Dec 29, 1975 | Supplement 80Manufacturing | Approved | None posted |
| Jul 8, 1975 | Supplement 79Manufacturing | Approved | None posted |
| Apr 25, 1974 | Supplement 78Manufacturing | Approved | None posted |
| Feb 28, 1974 | Supplement 77Labeling | Approved | None posted |
| Jan 10, 1974 | Supplement 76Manufacturing | Approved | None posted |
| Oct 1, 1973 | Supplement 73Labeling | Approved | None posted |
| Oct 1, 1973 | Supplement 74Labeling | Approved | None posted |
| Oct 1, 1973 | Supplement 75Labeling | Approved | None posted |
| Feb 16, 1972 | Supplement 70Labeling | Approved | None posted |
| Feb 16, 1972 | Supplement 71Manufacturing | Approved | None posted |
| Feb 16, 1972 | Supplement 72Manufacturing | Approved | None posted |
| Jan 10, 1972 | Supplement 67Labeling | Approved | None posted |
| Jan 10, 1972 | Supplement 68Labeling | Approved | None posted |
| Jan 10, 1972 | Supplement 69Labeling | Approved | None posted |
| Jul 14, 1971 | Supplement 66Labeling | Approved | None posted |
| Jun 14, 1971 | Supplement 65Manufacturing | Approved | None posted |
| Dec 1, 1970 | Supplement 64Manufacturing | Approved | None posted |
| Oct 23, 1970 | Supplement 62Manufacturing | Approved | None posted |
| Oct 23, 1970 | Supplement 63Manufacturing | Approved | None posted |
| Apr 14, 1970 | Supplement 61Manufacturing | Approved | None posted |
| Jan 3, 1969 | Supplement 60Manufacturing | Approved | None posted |
| Dec 7, 1967 | Supplement 59Labeling | Approved | None posted |
| Nov 17, 1967 | Supplement 58Labeling | Approved | None posted |
| Apr 25, 1967 | Supplement 55Labeling | Approved | None posted |
| Apr 25, 1967 | Supplement 56Labeling | Approved | None posted |
| Apr 25, 1967 | Supplement 57Labeling | Approved | None posted |
| Feb 20, 1967 | Supplement 53Labeling | Approved | None posted |
| Feb 15, 1967 | Supplement 54Labeling | Approved | None posted |
| Dec 29, 1966 | Supplement 51Manufacturing | Approved | None posted |
| Dec 29, 1966 | Supplement 52Manufacturing | Approved | None posted |
| Dec 5, 1966 | Supplement 44Labeling | Approved | None posted |
| Nov 29, 1966 | Supplement 50Labeling | Approved | None posted |
| Sep 28, 1966 | Supplement 45Labeling | Approved | None posted |
| Sep 28, 1966 | Supplement 46Labeling | Approved | None posted |
| Sep 15, 1966 | Supplement 43Manufacturing | Approved | None posted |
| Jul 6, 1966 | Supplement 42Labeling | Approved | None posted |
| Jun 3, 1966 | Supplement 41Labeling | Approved | None posted |
| May 4, 1966 | Supplement 31Labeling | Approved | None posted |
| May 4, 1966 | Supplement 32Labeling | Approved | None posted |
| May 4, 1966 | Supplement 33Labeling | Approved | None posted |
| May 4, 1966 | Supplement 34Labeling | Approved | None posted |
| May 4, 1966 | Supplement 35Labeling | Approved | None posted |
| May 4, 1966 | Supplement 36Labeling | Approved | None posted |
| May 4, 1966 | Supplement 37Labeling | Approved | None posted |
| May 4, 1966 | Supplement 38Labeling | Approved | None posted |
| May 4, 1966 | Supplement 39Labeling | Approved | None posted |
| May 4, 1966 | Supplement 40Labeling | Approved | None posted |
| Mar 25, 1966 | Supplement 30Labeling | Approved | None posted |
| Mar 14, 1966 | Supplement 27Labeling | Approved | None posted |
| Mar 11, 1966 | Supplement 29Labeling | Approved | None posted |
| Feb 18, 1966 | Supplement 28Labeling | Approved | None posted |
| Jan 13, 1966 | Supplement 22Labeling | Approved | None posted |
| Jan 13, 1966 | Supplement 23Labeling | Approved | None posted |
| Jan 5, 1966 | Supplement 25Labeling | Approved | None posted |
| Jan 5, 1966 | Supplement 26Labeling | Approved | None posted |
| Dec 23, 1965 | Supplement 19Efficacy (new indication or use) | Approved | None posted |
| Dec 22, 1965 | Supplement 24Labeling | Approved | None posted |
| Dec 13, 1965 | Supplement 20Labeling | Approved | None posted |
| Dec 7, 1965 | Supplement 21Labeling | Approved | None posted |
| Sep 24, 1965 | Supplement 17Manufacturing | Approved | None posted |
| Aug 19, 1965 | Supplement 18Labeling | Approved | None posted |
| May 14, 1965 | Supplement 15Manufacturing | Approved | None posted |
| May 14, 1965 | Supplement 16Manufacturing | Approved | None posted |
| Mar 11, 1965 | Supplement 14Labeling | Approved | None posted |
| Feb 10, 1965 | Supplement 3Labeling | Approved | None posted |
| Sep 22, 1964 | 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
