Treats acne vulgaris. ANDA 65513, held by Epic Pharma LLC. Clindamycin Phosphate.
As of Nov 15, 2026, ANDA 65513 (Clindamycin Phosphate), held by Epic Pharma LLC, was first approved by FDA on Jun 17, 2010, with 1 approved supplement 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 |
|---|---|---|---|
| Jun 17, 2010 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clindamycin PhosphateEQ 1% BASE · swab;topical | Clindamycin Phosphate | Rx |
| May 22, 2015 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jun 17, 2010 | 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
