Treats acne vulgaris. ANDA 209914, held by Encube Ethicals. Clindamycin Phosphate.
As of Nov 15, 2026, ANDA 209914 (Clindamycin Phosphate), held by Encube Ethicals, was first approved by FDA on Jan 28, 2019, with 3 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 |
|---|---|---|---|
| Jan 28, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clindamycin PhosphateEQ 1% BASE · solution;topical | Clindamycin Phosphate | Rx |
| Mar 18, 2021 | Supplement 3Manufacturing | Approved | None posted |
| Feb 12, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 12, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jan 28, 2019 | 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
