NDA 50262, held by Lederle. Demeclocycline Hydrochloride.
As of Nov 14, 2026, NDA 50262 (Declomycin), held by Lederle, was first approved by FDA on Jan 14, 1960, with 53 approved supplements and 0 published complete response letters.
| Aug 21, 1961 | Supplement 16Efficacy (new indication or use) | Approved | None posted |
| Aug 21, 1961 | Supplement 17Efficacy (new indication or use) | Approved | None posted |
| Apr 12, 1960 | Supplement 12Efficacy (new indication or use) | Approved | None posted |
| Mar 4, 1960 | Supplement 11Efficacy (new indication or use) | Approved | None posted |
| Jan 14, 1960 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Declomycin150MG · capsule;oral | Demeclocycline Hydrochloride | Discontinued |
| Nov 20, 1991 | Supplement 6Labeling | Approved | None posted |
| Nov 20, 1991 | Supplement 8Labeling | Approved | None posted |
| Oct 9, 1986 | Supplement 5Labeling | Approved | None posted |
| Jun 21, 1983 | Supplement 2Manufacturing | Approved | None posted |
| Mar 26, 1982 | Supplement 59Manufacturing | Approved | None posted |
| Oct 18, 1979 | Supplement 58Manufacturing | Approved | None posted |
| May 26, 1976 | Supplement 57Manufacturing | Approved | None posted |
| Feb 9, 1976 | Supplement 56Manufacturing | Approved | None posted |
| Mar 10, 1975 | Supplement 55Manufacturing | Approved | None posted |
| Feb 28, 1974 | Supplement 61Manufacturing | Approved | None posted |
| Oct 1, 1973 | Supplement 60Labeling | Approved | None posted |
| Sep 5, 1972 | Supplement 54Labeling | Approved | None posted |
| Feb 10, 1972 | Supplement 53Manufacturing | Approved | None posted |
| Jan 20, 1972 | Supplement 38Labeling | Approved | None posted |
| Jul 13, 1971 | Supplement 37Labeling | Approved | None posted |
| Jan 3, 1969 | Supplement 51Manufacturing | Approved | None posted |
| Oct 12, 1967 | Supplement 50Labeling | Approved | None posted |
| Sep 14, 1967 | Supplement 36Labeling | Approved | None posted |
| Jul 13, 1967 | Supplement 49Labeling | Approved | None posted |
| Jul 13, 1967 | Supplement 48Labeling | Approved | None posted |
| Jun 16, 1967 | Supplement 35Labeling | Approved | None posted |
| Sep 28, 1966 | Supplement 46Labeling | Approved | None posted |
| Jan 5, 1966 | Supplement 47Labeling | Approved | None posted |
| Dec 28, 1965 | Supplement 34Labeling | Approved | None posted |
| Oct 19, 1965 | Supplement 45Manufacturing | Approved | None posted |
| Sep 3, 1965 | Supplement 44Manufacturing | Approved | None posted |
| Sep 3, 1965 | Supplement 43Manufacturing | Approved | None posted |
| Sep 3, 1965 | Supplement 33Labeling | Approved | None posted |
| Aug 21, 1965 | Supplement 42Manufacturing | Approved | None posted |
| Aug 2, 1965 | Supplement 20Labeling | Approved | None posted |
| Mar 16, 1965 | Supplement 41Manufacturing | Approved | None posted |
| Mar 16, 1965 | Supplement 32Labeling | Approved | None posted |
| Feb 25, 1965 | Supplement 40Manufacturing | Approved | None posted |
| Feb 9, 1965 | Supplement 39Manufacturing | Approved | None posted |
| Aug 13, 1964 | Supplement 31Labeling | Approved | None posted |
| Jun 9, 1964 | Supplement 30Labeling | Approved | None posted |
| Jan 15, 1964 | Supplement 29Labeling | Approved | None posted |
| Jan 14, 1964 | Supplement 28Labeling | Approved | None posted |
| Nov 21, 1963 | Supplement 19Manufacturing | Approved | None posted |
| Nov 12, 1963 | Supplement 27Labeling | Approved | None posted |
| Jul 10, 1963 | Supplement 26Labeling | Approved | None posted |
| May 24, 1963 | Supplement 25Labeling | Approved | None posted |
| Jan 11, 1962 | Supplement 24Labeling | Approved | None posted |
| Oct 30, 1961 | Supplement 23Labeling | Approved | None posted |
| Aug 21, 1961 | Supplement 16Efficacy (new indication or use) | Approved | None posted |
| Aug 21, 1961 | Supplement 17Efficacy (new indication or use) | Approved | None posted |
| Aug 21, 1961 | Supplement 18Manufacturing | Approved | None posted |
| Jun 23, 1961 | Supplement 15Manufacturing | Approved | None posted |
| Dec 19, 1960 | Supplement 14Manufacturing | Approved | None posted |
| Nov 29, 1960 | Supplement 13Manufacturing | Approved | None posted |
| Apr 12, 1960 | Supplement 12Efficacy (new indication or use) | Approved | None posted |
| Mar 4, 1960 | Supplement 11Efficacy (new indication or use) | Approved | None posted |
| Feb 15, 1960 | Supplement 21Labeling | Approved | None posted |
| Jan 14, 1960 | 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
