Treats serious infections caused by susceptible anaerobic bacteria. NDA 50441, held by Pfizer. Clindamycin Phosphate.
As of Nov 13, 2026, NDA 50441 (Cleocin Phosphate), held by Pfizer, was first approved by FDA on Oct 2, 1972, with 35 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE CLEOCIN PHOSPHATE products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. CLEOCIN PHOSPHATE products are 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 2, 1972 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cleocin PhosphateEQ 150MG BASE/ML · injectable;injection | Clindamycin Phosphate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 26, 2026 | Supplement 91Labeling · Standard review | Approved | |
| Feb 12, 2026 | Supplement 90Labeling · Standard review | Approved | |
| May 20, 2022 | Supplement 85Labeling · Standard review | Approved | |
| Dec 4, 2021 | Supplement 86Labeling · Standard review | Approved | |
| Mar 4, 2020 | Supplement 83Labeling · Standard review | Approved | |
| Jun 19, 2019 | Supplement 81Labeling · Standard review | Approved | |
| Apr 16, 2018 | Supplement 79Labeling · Standard review | Approved | |
| May 2, 2017 | Supplement 78Labeling · Standard review | Approved | |
| May 2, 2017 | Supplement 76Labeling · Standard review | Approved | |
| Aug 5, 2016 | Supplement 73Labeling · Standard review | Approved | |
| Aug 5, 2016 | Supplement 72Labeling · Standard review | Approved | |
| Mar 24, 2016 | Supplement 71Labeling · Standard review | Approved | |
| Oct 20, 2014 | Supplement 70Manufacturing | Approved | None posted |
| Jun 10, 2014 | Supplement 68Labeling · Standard review | Approved | |
| Jun 10, 2014 | Supplement 67Labeling · Standard review | Approved | |
| Jun 10, 2014 | Supplement 66Labeling · Standard review | Approved | |
| Dec 18, 2012 | Supplement 64Manufacturing | Approved | None posted |
| Jun 7, 2011 | Supplement 61Labeling | Approved | |
| Oct 15, 2010 | Supplement 59Labeling | Approved | |
| Apr 14, 2008 | Supplement 55Labeling · Standard review | Approved | |
| Feb 21, 2008 | Supplement 53Labeling · Standard review | Approved | |
| Sep 29, 2004 | Supplement 45Labeling · Standard review | Approved | |
| Jan 28, 2004 | Supplement 48Labeling · Standard review | Approved | |
| Nov 21, 2001 | Supplement 47Labeling · Standard review | Approved | |
| Apr 3, 2000 | Supplement 46Manufacturing | Approved | None posted |
| Dec 12, 1997 | Supplement 44Labeling · Standard review | Approved | None posted |
| Jul 17, 1997 | Supplement 43Labeling · Standard review | Approved | None posted |
| Mar 17, 1997 | Supplement 38Labeling | Approved | None posted |
| Mar 17, 1997 | Supplement 25Labeling | Approved | None posted |
| Mar 17, 1997 | Supplement 23Labeling | Approved | None posted |
| Mar 5, 1996 | Supplement 40Labeling | Approved | None posted |
| Dec 20, 1995 | Supplement 41Labeling · Standard review | Approved | None posted |
| Feb 21, 1995 | Supplement 42Labeling | Approved | None posted |
| Mar 23, 1993 | Supplement 37Manufacturing | Approved | None posted |
| Jun 11, 1991 | Supplement 35Labeling | Approved | None posted |
| Oct 2, 1972 | 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
