Treats acne vulgaris. ANDA 219612, held by Carnegie. Clindamycin Phosphate.
As of Nov 15, 2026, ANDA 219612 (Clindamycin Phosphate), held by Carnegie, was first approved by FDA on Jun 13, 2025, with 0 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 |
|---|---|---|---|
| Jun 13, 2025 | 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
