Treats bacterial vaginosis in non-pregnant women. NDA 50767, held by Pfizer. Clindamycin Phosphate.
As of Nov 13, 2026, NDA 50767 (Cleocin), held by Pfizer, was first approved by FDA on Aug 13, 1999, with 10 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE CLEOCIN Vaginal Ovules are indicated for 3-day treatment of bacterial vaginosis in non-pregnant women. There are no adequate and well-controlled studies of CLEOCIN Vaginal Ovules in pregnant women. NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 13, 1999 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cleocin100MG · suppository;vaginal | Clindamycin Phosphate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 26, 2022 | Supplement 19Labeling · Standard review | Approved | |
| May 17, 2022 | Supplement 18Labeling · Standard review | Approved | |
| Mar 23, 2020 | Supplement 17Labeling · Standard review | Approved | |
| Sep 16, 2019 | Supplement 16Labeling · Standard review | Approved | |
| Dec 20, 2018 | Supplement 15Labeling · Standard review | Approved | |
| Sep 8, 2017 | Supplement 14Labeling · Standard review | Approved | |
| Jul 13, 2015 | Supplement 12Labeling · Standard review | Approved | |
| May 9, 2014 | Supplement 11Labeling · Standard review | Approved | |
| Jun 19, 2013 | Supplement 10Labeling · Standard review | Approved | |
| May 15, 2000 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Aug 13, 1999 | Original applicationNew dosage form · 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
