Treats acne vulgaris. ANDA 64050, held by Padagis US. Clindamycin Phosphate.
As of Nov 15, 2026, ANDA 64050 (Clindamycin Phosphate), held by Padagis US, was first approved by FDA on Nov 30, 1995, with 9 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 |
|---|---|---|---|
| Nov 30, 1995 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clindamycin PhosphateEQ 1% BASE · solution;topical | Clindamycin Phosphate | Rx |
| Jun 10, 2026 | Supplement 28Labeling · Standard review | Approved | None posted |
| Apr 26, 2024 | Supplement 24Manufacturing | Approved | None posted |
| May 11, 2023 | Supplement 22Labeling · Standard review | Approved | None posted |
| May 12, 2016 | Supplement 9Labeling · Standard review | Approved | None posted |
| May 12, 2016 | Supplement 10Labeling · Standard review | Approved | None posted |
| May 12, 2016 | Supplement 12Labeling · Standard review | Approved | None posted |
| Apr 5, 2001 | Supplement 6Manufacturing | Approved | None posted |
| Nov 8, 1999 | Supplement 3Manufacturing | Approved | None posted |
| May 19, 1998 | Supplement 2Manufacturing | Approved | None posted |
| Nov 30, 1995 | 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
