NDA 50782, held by Bausch. Clindamycin Phosphate.
As of Nov 13, 2026, NDA 50782 (Clindagel), held by Bausch, was first approved by FDA on Nov 27, 2000, with 0 approved supplements and 0 published complete response letters.
CLINICAL STUDIES In one 12-week multicenter, randomized, evaluator-blind, vehicle-controlled, parallel comparison clinical trial in which patients used Clindamycin Phosphate Topical Gel, 1%, once daily or the vehicle gel once daily, in the treatment of acne vulgaris of mild to moderate severity, Clindamycin Phosphate Topical Gel applied once daily was more effective than the vehicle applied once daily. The mean percent reductions in lesion counts at the end of treatment in this study are shown in the following table: Lesions Clindamycin Phosphate Topical Gel QD N=162 Vehicle Gel QD N=82 Inflammatory 51% 40% P<0.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 27, 2000 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| ClindagelEQ 1% BASE · gel;topical | Clindamycin Phosphate | RxReference drug |
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
