Treats acne vulgaris. ANDA 208767, held by Zydus Lifesciences. Clindamycin Phosphate.
As of Nov 15, 2026, ANDA 208767 (Clindamycin Phosphate), held by Zydus Lifesciences, was first approved by FDA on Jul 16, 2018, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Clindamycin phosphate topical solution 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 |
|---|---|---|---|
| Jul 16, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clindamycin PhosphateEQ 1% BASE · solution;topical | Clindamycin Phosphate | Rx |
| Apr 26, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Apr 26, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jul 16, 2018 | 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
