Treats acne vulgaris. ANDA 214052, held by Sun Pharma Canada. Clindamycin Phosphate.
As of Nov 15, 2026, ANDA 214052 (Clindamycin Phosphate), held by Sun Pharma Canada, was first approved by FDA on Nov 10, 2020, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Clindamycin phosphate gel USP, 1% 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 |
|---|---|---|---|
| Nov 10, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clindamycin PhosphateEQ 1% BASE · gel;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
