Treats acne vulgaris. ANDA 65184, held by Taro Pharm Inds. Clindamycin Phosphate.
As of Nov 15, 2026, ANDA 65184 (Clindamycin Phosphate), held by Taro Pharm Inds, was first approved by FDA on Mar 31, 2004, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Clindamycin Phosphate Topical Solution is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS ).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 31, 2004 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clindamycin PhosphateEQ 1% BASE · solution;topical | Clindamycin Phosphate | Rx |
| Aug 16, 2019 | Supplement 9Labeling · Standard review | Approved | None posted |
| Sep 1, 2016 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 1, 2016 | Supplement 3Labeling · Standard review | Approved | None posted |
| Mar 31, 2004 | 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
