NDA 215650, held by Organon LLC. Clindamycin Phosphate.
As of Nov 13, 2026, NDA 215650 (Xaciato), held by Organon LLC, was first approved by FDA on Dec 7, 2021, with 1 approved supplement and 0 published complete response letters.
XACIATO is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older. 1.1 Bacterial Vaginosis
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 7, 2021 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| XaciatoEQ 2% BASE · gel;vaginal | Clindamycin Phosphate | RxReference drug |
| Mar 6, 2023 | Supplement 3Labeling · Standard review | Approved | |
| Dec 7, 2021 | Original applicationNew formulation or manufacturer · Priority 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
