Treats acne vulgaris. ANDA 212104, held by Padagis Israel. Clindamycin Phosphate.
As of Nov 15, 2026, ANDA 212104 (Clindamycin Phosphate), held by Padagis Israel, was first approved by FDA on Dec 31, 2020, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Clindamycin Phosphate Gel 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 |
|---|---|---|---|
| Dec 31, 2020 | 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
