ANDA 204748, held by Rising. Clindamycin Phosphate.
As of Nov 15, 2026, ANDA 204748 (Clindamycin Phosphate), held by Rising, was first approved by FDA on Oct 10, 2017, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 10, 2017 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clindamycin PhosphateEQ 150MG BASE/ML · injectable;injection | Clindamycin Phosphate | Discontinued |
| Apr 7, 2025 | Supplement 1Labeling · Standard review | Approved | None posted |
| Apr 7, 2025 | Supplement 3Labeling · Standard review | Approved | None posted |
| Apr 7, 2025 | Supplement 5Labeling · Standard review | Approved | None posted |
| Apr 7, 2025 | Supplement 8Labeling · Standard review | Approved | None posted |
| Oct 10, 2017 | Original application | Approved |
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
