Treats acne vulgaris. ANDA 212438, held by Encube. Clindamycin Phosphate.
As of Nov 15, 2026, ANDA 212438 (Clindamycin Phosphate), held by Encube, was first approved by FDA on Mar 11, 2021, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Clindamycin phosphate gel, 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 |
|---|---|---|---|
| Mar 11, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clindamycin PhosphateEQ 1% BASE · gel;topical | Clindamycin Phosphate | Rx |
| May 18, 2026 | Supplement 14Manufacturing | Approved | None posted |
| Mar 11, 2021 | 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
