Treats vulvovaginal candidiasis (moniliasis). NDA 21735, held by Fougera. Terconazole.
As of Nov 14, 2026, NDA 21735 (Terconazole), held by Fougera, was first approved by FDA on Oct 1, 2004, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Terconazole vaginal cream 0.8% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole vaginal cream 0.8% is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 1, 2004 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Terconazole0.8% · cream;vaginal | Terconazole | RxReference drug |
| Aug 22, 2025 | Supplement 14Labeling · Standard review | Approved | |
| Jan 16, 2013 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Dec 30, 2010 | Supplement 4Labeling | Approved | |
| Oct 1, 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
