NDA 50316, held by Pharmacia And Upjohn. Lincomycin Hydrochloride.
As of Nov 13, 2026, NDA 50316 (Lincocin), held by Pharmacia And Upjohn, was first approved by FDA on Dec 29, 1964, with 89 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 29, 1964 | Original application | Approved | None posted |
| LincocinEQ 250MG BASE · capsule;oral | Lincomycin Hydrochloride | Discontinued |
| LincocinEQ 500MG BASE · capsule;oral | Lincomycin Hydrochloride | Discontinued |
| Jun 2, 2004 | Supplement 99Labeling · Standard review | Approved | |
| Oct 30, 2001 | Supplement 98Manufacturing | Approved | None posted |
| Oct 28, 1998 | Supplement 6Labeling | Approved | None posted |
| Feb 18, 1993 | Supplement 8Manufacturing | Approved | None posted |
| Aug 29, 1991 | Supplement 7Labeling | Approved | None posted |
| Jun 21, 1985 | Supplement 96Labeling | Approved | None posted |
| Jun 3, 1985 | Supplement 95Labeling | Approved | None posted |
| Nov 20, 1982 | Supplement 94Labeling | Approved | None posted |
| Aug 3, 1982 | Supplement 93Manufacturing | Approved | None posted |
| Mar 5, 1982 | Supplement 92Labeling | Approved | None posted |
| Sep 4, 1981 | Supplement 91Manufacturing | Approved | None posted |
| Nov 19, 1980 | Supplement 90Manufacturing | Approved | None posted |
| Oct 15, 1980 | Supplement 89Labeling | Approved | None posted |
| Aug 6, 1980 | Supplement 88Manufacturing | Approved | None posted |
| Jun 20, 1979 | Supplement 87Manufacturing | Approved | None posted |
| Apr 26, 1979 | Supplement 86Labeling | Approved | None posted |
| Mar 30, 1979 | Supplement 85Labeling | Approved | None posted |
| Jul 10, 1978 | Supplement 84Labeling | Approved | None posted |
| Jun 26, 1978 | Supplement 83Manufacturing | Approved | None posted |
| Feb 27, 1978 | Supplement 82Labeling | Approved | None posted |
| Jun 29, 1977 | Supplement 81Manufacturing | Approved | None posted |
| Mar 29, 1977 | Supplement 80Labeling | Approved | None posted |
| Aug 16, 1976 | Supplement 79Labeling | Approved | None posted |
| Jul 9, 1976 | Supplement 75Labeling | Approved | None posted |
| Apr 21, 1976 | Supplement 78Labeling | Approved | None posted |
| Dec 29, 1975 | Supplement 77Manufacturing | Approved | None posted |
| Nov 12, 1975 | Supplement 76Labeling | Approved | None posted |
| Mar 14, 1975 | Supplement 74Labeling | Approved | None posted |
| Aug 26, 1974 | Supplement 73Labeling | Approved | None posted |
| Aug 9, 1974 | Supplement 72Labeling | Approved | None posted |
| Aug 6, 1974 | Supplement 71Manufacturing | Approved | None posted |
| Aug 6, 1974 | Supplement 70Labeling | Approved | None posted |
| Aug 6, 1974 | Supplement 69Labeling | Approved | None posted |
| Jan 29, 1974 | Supplement 68Labeling | Approved | None posted |
| Nov 15, 1973 | Supplement 67Labeling | Approved | None posted |
| May 10, 1973 | Supplement 66Labeling | Approved | None posted |
| Mar 15, 1973 | Supplement 65Manufacturing | Approved | None posted |
| Sep 5, 1972 | Supplement 63Labeling | Approved | None posted |
| Jul 31, 1972 | Supplement 62Manufacturing | Approved | None posted |
| Jun 6, 1972 | Supplement 61Labeling | Approved | None posted |
| Oct 28, 1971 | Supplement 54Labeling | Approved | None posted |
| Oct 14, 1971 | Supplement 58Labeling | Approved | None posted |
| Sep 27, 1971 | Supplement 57Labeling | Approved | None posted |
| Sep 23, 1971 | Supplement 56Labeling | Approved | None posted |
| Jul 22, 1971 | Supplement 55Manufacturing | Approved | None posted |
| May 27, 1971 | Supplement 53Manufacturing | Approved | None posted |
| May 27, 1971 | Supplement 52Manufacturing | Approved | None posted |
| Mar 10, 1971 | Supplement 51Manufacturing | Approved | None posted |
| Feb 18, 1971 | Supplement 50Labeling | Approved | None posted |
| Feb 8, 1971 | Supplement 49Labeling | Approved | None posted |
| Dec 9, 1970 | Supplement 48Labeling | Approved | None posted |
| Nov 18, 1970 | Supplement 47Labeling | Approved | None posted |
| Sep 10, 1970 | Supplement 46Labeling | Approved | None posted |
| Sep 4, 1970 | Supplement 45Labeling | Approved | None posted |
| Aug 21, 1970 | Supplement 43Manufacturing | Approved | None posted |
| Aug 7, 1970 | Supplement 44Labeling | Approved | None posted |
| Jun 30, 1970 | Supplement 42Labeling | Approved | None posted |
| Jun 10, 1970 | Supplement 29Labeling | Approved | None posted |
| Jun 5, 1970 | Supplement 41Labeling | Approved | None posted |
| May 25, 1970 | Supplement 40Labeling | Approved | None posted |
| Apr 1, 1970 | Supplement 39Manufacturing | Approved | None posted |
| Mar 27, 1970 | Supplement 38Labeling | Approved | None posted |
| Mar 3, 1970 | Supplement 37Labeling | Approved | None posted |
| Jan 22, 1970 | Supplement 35Labeling | Approved | None posted |
| Jun 27, 1969 | Supplement 34Labeling | Approved | None posted |
| Jun 9, 1969 | Supplement 33Labeling | Approved | None posted |
| Apr 10, 1969 | Supplement 32Labeling | Approved | None posted |
| Mar 3, 1969 | Supplement 31Labeling | Approved | None posted |
| Feb 28, 1969 | Supplement 30Manufacturing | Approved | None posted |
| Jul 12, 1968 | Supplement 28Manufacturing | Approved | None posted |
| Apr 24, 1968 | Supplement 27Labeling | Approved | None posted |
| Mar 11, 1968 | Supplement 26Manufacturing | Approved | None posted |
| Jan 23, 1968 | Supplement 25Labeling | Approved | None posted |
| Dec 19, 1967 | Supplement 24Labeling | Approved | None posted |
| Oct 27, 1967 | Supplement 23Labeling | Approved | None posted |
| Oct 16, 1967 | Supplement 22Labeling | Approved | None posted |
| Aug 22, 1967 | Supplement 21Labeling | Approved | None posted |
| Aug 16, 1967 | Supplement 20Labeling | Approved | None posted |
| Aug 9, 1967 | Supplement 19Labeling | Approved | None posted |
| Jul 20, 1967 | Supplement 18Labeling | Approved | None posted |
| Jun 30, 1967 | Supplement 17Labeling | Approved | None posted |
| May 19, 1967 | Supplement 16Labeling | Approved | None posted |
| Feb 1, 1967 | Supplement 15Labeling | Approved | None posted |
| Dec 28, 1966 | Supplement 14Labeling | Approved | None posted |
| Dec 22, 1966 | Supplement 12Labeling | Approved | None posted |
| Dec 15, 1966 | Supplement 13Labeling | Approved | None posted |
| Nov 28, 1966 | Supplement 10Labeling | Approved | None posted |
| May 10, 1966 | Supplement 9Labeling | Approved | None posted |
| Apr 2, 1965 | Supplement 1Manufacturing | Approved | None posted |
| Dec 29, 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
