ANDA 65139, held by Fougera Pharms. Clindamycin Phosphate.
As of Nov 15, 2026, ANDA 65139 (Clindamycin Phosphate), held by Fougera Pharms, was first approved by FDA on Dec 27, 2004, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Clindamycin phosphate vaginal cream 2%, is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). Clindamycin phosphate vaginal cream 2%, can be used to treat non-pregnant women and pregnant women during the second and third trimester. (See CLINICAL STUDIES. ) 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 27, 2004 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clindamycin PhosphateEQ 2% BASE · cream;vaginal | Clindamycin Phosphate | Rx |
| Feb 8, 2023 | Supplement 8Labeling · Standard review | Approved | None posted |
| Feb 8, 2023 | Supplement 9Labeling · Standard review | Approved | None posted |
| Feb 8, 2023 | Supplement 10Labeling · Standard review | Approved | None posted |
| Feb 8, 2023 | Supplement 12Labeling · Standard review | Approved | None posted |
| Dec 27, 2004 | Original application | 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
