Treats acne vulgaris. ANDA 214668, held by Amneal. Clindamycin Phosphate.
As of Nov 15, 2026, ANDA 214668 (Clindamycin Phosphate), held by Amneal, was first approved by FDA on Aug 5, 2022, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Clindamycin phosphate gel, 1% is indicated for topical application 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 |
|---|---|---|---|
| Aug 5, 2022 | Original application | Approved |
| 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
