Treats serious infections caused by susceptible anaerobic bacteria. NDA 50162, held by Pfizer. Clindamycin Hydrochloride.
As of Nov 15, 2026, NDA 50162 (Cleocin Hydrochloride), held by Pfizer, was first approved by FDA on Feb 22, 1970, with 90 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).
| Apr 14, 1988 | Supplement 11Efficacy (new indication or use) | Approved | None posted |
| Nov 3, 1981 | Supplement 76Efficacy (new indication or use) | Approved | None posted |
| May 22, 1970 | Supplement 1Efficacy (new indication or use) | Approved | None posted |
| Feb 22, 1970 | Original application | Approved | None posted |
| Cleocin HydrochlorideEQ 75MG BASE · capsule;oral | Clindamycin Hydrochloride | RxReference drug |
| Cleocin HydrochlorideEQ 150MG BASE · capsule;oral | Clindamycin Hydrochloride | RxReference drug |
| Cleocin HydrochlorideEQ 300MG BASE · capsule;oral | Clindamycin Hydrochloride | RxReference drug |
| Sep 1, 2026 | Supplement 108Labeling · Standard review | Approved | |
| Mar 26, 2026 | Supplement 107Labeling · Standard review | Approved | |
| Feb 12, 2026 | Supplement 106Labeling · Standard review | Approved | |
| Jul 29, 2024 | Supplement 105Labeling · Standard review | Approved | |
| May 20, 2022 | Supplement 104Labeling · Standard review | Approved | |
| Mar 9, 2020 | Supplement 102Labeling · Standard review | Approved | |
| Jun 13, 2019 | Supplement 101Labeling · Standard review | Approved | |
| Mar 15, 2018 | Supplement 100Labeling · Standard review | Approved | |
| May 2, 2017 | Supplement 98Labeling · Standard review | Approved | |
| May 2, 2017 | Supplement 99Labeling · Standard review | Approved | |
| Aug 2, 2016 | Supplement 97Labeling · Standard review | Approved | None posted |
| Mar 23, 2016 | Supplement 95Labeling · Standard review | Approved | |
| Mar 23, 2016 | Supplement 96Labeling · Standard review | Approved | |
| Jan 21, 2016 | Supplement 94Manufacturing | Approved | None posted |
| Jun 26, 2014 | Supplement 92Labeling · Standard review | Approved | |
| Jun 26, 2014 | Supplement 93Labeling · Standard review | Approved | |
| Jun 7, 2011 | Supplement 90Labeling | Approved | |
| Nov 20, 2009 | Supplement 85Labeling · Standard review | Approved | |
| Sep 29, 2004 | Supplement 82Labeling · Standard review | Approved | |
| Jan 28, 2004 | Supplement 84Labeling · Standard review | Approved | |
| Nov 15, 1999 | Supplement 83Manufacturing | Approved | None posted |
| Feb 24, 1998 | Supplement 81Manufacturing | Approved | None posted |
| Dec 12, 1997 | Supplement 80Labeling · Standard review | Approved | None posted |
| Jul 17, 1997 | Supplement 79Labeling · Standard review | Approved | None posted |
| Mar 17, 1997 | Supplement 9Labeling | Approved | None posted |
| Mar 17, 1997 | Supplement 18Labeling | Approved | None posted |
| Mar 17, 1997 | Supplement 22Labeling | Approved | None posted |
| Feb 21, 1995 | Supplement 20Labeling | Approved | None posted |
| Mar 5, 1993 | Supplement 21Manufacturing | Approved | None posted |
| Apr 14, 1988 | Supplement 11Efficacy (new indication or use) | Approved | None posted |
| Oct 20, 1986 | Supplement 10Labeling | Approved | None posted |
| Sep 10, 1985 | Supplement 5Labeling | Approved | None posted |
| Jun 21, 1985 | Supplement 7Labeling | Approved | None posted |
| Apr 29, 1983 | Supplement 4Manufacturing | Approved | None posted |
| Apr 27, 1982 | Supplement 77Manufacturing | Approved | None posted |
| Nov 3, 1981 | Supplement 76Efficacy (new indication or use) | Approved | None posted |
| May 20, 1981 | Supplement 75Manufacturing | Approved | None posted |
| May 27, 1980 | Supplement 74Manufacturing | Approved | None posted |
| Apr 30, 1980 | Supplement 73Labeling | Approved | None posted |
| Nov 6, 1979 | Supplement 72Labeling | Approved | None posted |
| Jul 20, 1979 | Supplement 71Manufacturing | Approved | None posted |
| Jul 9, 1979 | Supplement 70Labeling | Approved | None posted |
| Jul 9, 1979 | Supplement 69Labeling | Approved | None posted |
| Jun 28, 1979 | Supplement 64Labeling | Approved | None posted |
| May 18, 1979 | Supplement 68Manufacturing | Approved | None posted |
| Apr 24, 1979 | Supplement 67Labeling | Approved | None posted |
| Oct 4, 1978 | Supplement 66Labeling | Approved | None posted |
| Jul 11, 1978 | Supplement 63Labeling | Approved | None posted |
| Feb 14, 1978 | Supplement 62Manufacturing | Approved | None posted |
| Aug 15, 1977 | Supplement 57Labeling | Approved | None posted |
| Jan 3, 1977 | Supplement 61Labeling | Approved | None posted |
| Jul 2, 1976 | Supplement 60Manufacturing | Approved | None posted |
| Jun 2, 1976 | Supplement 59Manufacturing | Approved | None posted |
| Jan 28, 1976 | Supplement 58Manufacturing | Approved | None posted |
| Nov 17, 1975 | Supplement 56Labeling | Approved | None posted |
| Jun 11, 1975 | Supplement 55Labeling | Approved | None posted |
| Mar 17, 1975 | Supplement 54Labeling | Approved | None posted |
| Mar 14, 1975 | Supplement 53Labeling | Approved | None posted |
| Aug 16, 1974 | Supplement 50Labeling | Approved | None posted |
| Aug 9, 1974 | Supplement 52Labeling | Approved | None posted |
| Jun 6, 1974 | Supplement 51Manufacturing | Approved | None posted |
| Apr 24, 1974 | Supplement 44Labeling | Approved | None posted |
| Apr 24, 1974 | Supplement 45Labeling | Approved | None posted |
| Nov 6, 1973 | Supplement 48Manufacturing | Approved | None posted |
| Oct 16, 1973 | Supplement 47Labeling | Approved | None posted |
| Jul 20, 1973 | Supplement 46Manufacturing | Approved | None posted |
| Jul 19, 1973 | Supplement 42Labeling | Approved | None posted |
| Apr 3, 1973 | Supplement 43Labeling | Approved | None posted |
| Jan 12, 1973 | Supplement 41Manufacturing | Approved | None posted |
| Aug 10, 1972 | Supplement 37Labeling | Approved | None posted |
| Jul 25, 1972 | Supplement 40Labeling | Approved | None posted |
| Jul 14, 1972 | Supplement 38Manufacturing | Approved | None posted |
| May 22, 1972 | Supplement 32Manufacturing | Approved | None posted |
| May 11, 1972 | Supplement 36Manufacturing | Approved | None posted |
| Apr 12, 1972 | Supplement 34Labeling | Approved | None posted |
| Feb 15, 1972 | Supplement 27Labeling | Approved | None posted |
| Feb 15, 1972 | Supplement 33Labeling | Approved | None posted |
| Sep 22, 1971 | Supplement 29Labeling | Approved | None posted |
| Jul 22, 1971 | Supplement 24Labeling | Approved | None posted |
| Jun 14, 1971 | Supplement 28Manufacturing | Approved | None posted |
| May 18, 1971 | Supplement 17Labeling | Approved | None posted |
| Apr 26, 1971 | Supplement 12Labeling | Approved | None posted |
| Feb 19, 1971 | Supplement 19Labeling | Approved | None posted |
| Dec 18, 1970 | Supplement 16Labeling | Approved | None posted |
| Dec 15, 1970 | Supplement 15Labeling | Approved | None posted |
| Dec 9, 1970 | Supplement 14Labeling | Approved | None posted |
| Nov 16, 1970 | Supplement 13Labeling | Approved | None posted |
| Sep 21, 1970 | Supplement 6Manufacturing | Approved | None posted |
| Jul 1, 1970 | Supplement 3Manufacturing | Approved | None posted |
| May 22, 1970 | Supplement 1Efficacy (new indication or use) | Approved | None posted |
| Feb 22, 1970 | 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
