ANDA 62803, held by Pfizer. Clindamycin Phosphate.
As of Nov 15, 2026, ANDA 62803 (Cleocin Phosphate), held by Pfizer, was first approved by FDA on Oct 16, 1987, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 16, 1987 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cleocin PhosphateEQ 150MG BASE/ML · injectable;injection | Clindamycin Phosphate | Rx |
| Sep 11, 2017 | Supplement 35Labeling · Standard review | Approved | None posted |
| Aug 18, 2016 | Supplement 25Labeling · Standard review | Approved | None posted |
| Aug 18, 2016 | Supplement 26Labeling · Standard review | Approved | None posted |
| Aug 18, 2016 | Supplement 27Labeling · Standard review | Approved | None posted |
| Aug 18, 2016 | Supplement 31Labeling · Standard review | Approved | None posted |
| Aug 18, 2016 | Supplement 32Labeling · Standard review | Approved | None posted |
| Apr 5, 2000 | Supplement 12Manufacturing | Approved | None posted |
| Oct 1, 1998 | Supplement 11Labeling | Approved | None posted |
| Jan 12, 1998 | Supplement 6Labeling | Approved | None posted |
| Apr 30, 1996 | Supplement 4Labeling | Approved | None posted |
| Feb 2, 1996 | Supplement 10Manufacturing | Approved | None posted |
| Sep 23, 1993 | Supplement 8Labeling | Approved | None posted |
| Oct 30, 1992 | Supplement 9Manufacturing | Approved | None posted |
| Jul 6, 1992 | Supplement 5Manufacturing | Approved | None posted |
| Mar 22, 1990 | Supplement 3Manufacturing | Approved | None posted |
| Oct 16, 1987 | 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
