Treats acne vulgaris. ANDA 210778, held by Glenmark Pharms Ltd. Clindamycin Phosphate.
As of Nov 15, 2026, ANDA 210778 (Clindamycin Phosphate), held by Glenmark Pharms Ltd, was first approved by FDA on Sep 20, 2021, with 0 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 |
|---|---|---|---|
| Sep 20, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clindamycin Phosphate1% · aerosol, foam;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
