Treats acne vulgaris. ANDA 212842, held by Solaris Pharma Corp. Clindamycin Phosphate.
As of Nov 15, 2026, ANDA 212842 (Clindamycin Phosphate), held by Solaris Pharma Corp, was first approved by FDA on Aug 13, 2021, 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 13, 2021 | 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
