Treats acne vulgaris. ANDA 90785, held by Padagis Israel. Clindamycin Phosphate.
As of Nov 15, 2026, ANDA 90785 (Clindamycin Phosphate), held by Padagis Israel, was first approved by FDA on Mar 31, 2010, with 2 approved supplements and 0 published complete response letters.
Clindamycin phosphate foam is indicated for topical application in the treatment of acne vulgaris in patients 12 years and older. Clindamycin phosphate foam is a lincosamide product indicated for acne vulgaris in patients 12 years and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 31, 2010 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clindamycin Phosphate1% · aerosol, foam;topical | Clindamycin Phosphate | Rx |
| Feb 5, 2024 | Supplement 18Labeling · Standard review | Approved | None posted |
| Nov 30, 2012 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 31, 2010 | 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
