Treats bacterial vaginosis in non-pregnant women. NDA 50793, held by Padagis US. Clindamycin Phosphate.
As of Nov 13, 2026, NDA 50793 (Clindesse), held by Padagis US, was first approved by FDA on Nov 30, 2004, with 10 approved supplements and 0 published complete response letters.
Clindesse is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in non-pregnant women 1.1 Treatment of Bacterial Vaginosis
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 30, 2004 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| ClindesseEQ 2% BASE · cream;vaginal | Clindamycin Phosphate | RxReference drug |
| Jan 30, 2025 | Supplement 33Labeling · Standard review | Approved | |
| Nov 3, 2023 | Supplement 31Labeling · Standard review | Approved | |
| Jan 18, 2017 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Mar 1, 2016 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Feb 11, 2016 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Sep 22, 2014 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Apr 9, 2013 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Jan 16, 2013 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Feb 15, 2012 | Supplement 15Labeling | Approved | |
| Dec 15, 2010 | Supplement 14Labeling | Approved | |
| Nov 30, 2004 | Original applicationNew formulation or manufacturer · Standard review | 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
