Treats acne vulgaris. ANDA 64159, held by Fougera Pharms Inc. Clindamycin Phosphate.
As of Nov 15, 2026, ANDA 64159 (Clindamycin Phosphate), held by Fougera Pharms Inc, was first approved by FDA on Jun 5, 1997, with 8 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Clindamycin Phosphate Topical Solution, Clindamycin Phosphate Gel, and Clindamycin Phosphate Topical Lotion are 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 |
|---|---|---|---|
| Jun 5, 1997 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clindamycin PhosphateEQ 1% BASE · solution;topical | Clindamycin Phosphate | Rx |
| Aug 22, 2025 | Supplement 13Labeling · Standard review | Approved | None posted |
| Aug 22, 2025 | Supplement 16Labeling · Standard review | Approved | None posted |
| Aug 22, 2025 | Supplement 17Labeling · Standard review | Approved | None posted |
| Aug 22, 2025 | Supplement 19Labeling · Standard review | Approved | None posted |
| Aug 22, 2025 | Supplement 20Labeling · Standard review | Approved | None posted |
| Jun 2, 2005 | Supplement 4Labeling | Approved | None posted |
| Jun 16, 2004 | Supplement 2Labeling | Approved | None posted |
| Feb 26, 2001 | Supplement 1Manufacturing | Approved | None posted |
| Jun 5, 1997 | Original application | Approved |
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
