Treats acne vulgaris. ANDA 218300, held by Rising. Clindamycin Phosphate.
As of Nov 15, 2026, ANDA 218300 (Clindamycin Phosphate), held by Rising, was first approved by FDA on Mar 23, 2026, with 0 approved supplements and 0 published complete response letters.
INDICATIONS & 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 23, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clindamycin PhosphateEQ 1% BASE · swab;topical | Clindamycin Phosphate | Rx |
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
