Treats acne vulgaris. ANDA 64160, held by Fougera Pharms. Clindamycin Phosphate.
As of Nov 15, 2026, ANDA 64160 (Clindamycin Phosphate), held by Fougera Pharms, was first approved by FDA on Jan 28, 2000, with 10 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 |
|---|---|---|---|
| Jan 28, 2000 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clindamycin PhosphateEQ 1% BASE · gel;topical | Clindamycin Phosphate | Rx |
| Aug 22, 2025 | Supplement 15Labeling · Standard review | Approved | None posted |
| Aug 22, 2025 | Supplement 18Labeling · Standard review | Approved | None posted |
| Aug 22, 2025 | Supplement 20Labeling · Standard review | Approved | None posted |
| Aug 22, 2025 | Supplement 24Labeling · Standard review | Approved | None posted |
| Aug 22, 2025 | Supplement 26Labeling · Standard review | Approved | None posted |
| Jun 2, 2005 | Supplement 8Labeling | Approved | None posted |
| Jun 16, 2004 | Supplement 6Labeling | Approved | None posted |
| Mar 31, 2003 | Supplement 5Labeling | Approved | None posted |
| Dec 16, 2002 | Supplement 2Labeling | Approved | None posted |
| Jul 27, 2001 | Supplement 1Manufacturing | Approved | None posted |
| Jan 28, 2000 | 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
