Treats acne vulgaris. ANDA 216587, held by Zydus Lifesciences. Clindamycin Phosphate.
As of Nov 15, 2026, ANDA 216587 (Clindamycin Phosphate), held by Zydus Lifesciences, was first approved by FDA on Sep 19, 2023, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Clindamycin phosphate gel 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 |
|---|---|---|---|
| Sep 19, 2023 | 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
