NDA 21806, held by Teva Pharms. Metronidazole.
As of Nov 14, 2026, NDA 21806 (Vandazole), held by Teva Pharms, was first approved by FDA on May 20, 2005, with 4 approved supplements and 0 published complete response letters.
VANDAZOLE is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in post-menarchal females. VANDAZOLE is a nitroimidazole antimicrobial indicated for the treatment of bacterial vaginosis in post-menarchal females.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 20, 2005 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vandazole0.75% · gel;vaginal | Metronidazole | Rx |
| Feb 11, 2021 | Supplement 8Labeling · Standard review | Approved | |
| Jan 29, 2014 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Feb 3, 2011 | Supplement 3Labeling | Approved | |
| Sep 7, 2006 | Supplement 1Manufacturing | Approved | None posted |
| May 20, 2005 | 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
