terconazole

FDA Drug Profile — Terconazole Vaginal Cream 0.8%, Terconazole

terconazole is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand names including Terconazole Vaginal Cream 0.8%, Terconazole. Available dosage form: cream.

Drug Details

Generic Name
terconazole
Brand Names
Terconazole Vaginal Cream 0.8%, Terconazole
Application Number
NDA021735
Sponsor
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
NDC Codes
4
Dosage Forms
CREAM
Routes
VAGINAL
Active Ingredients
TERCONAZOLE

Indications and Usage

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.

Warnings

WARNINGS None.