Application Nr Approved Date Route Status External Links
ANDA076043 2005-01-19 Vaginal RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Terconazole Vaginal Cream 0.4% Is Indicated For The Local Treatment Of Vulvovaginal Candidiasis (moniliasis). As Terconazole Vaginal Cream 0.4% Is Effective Only For Vulvovaginitis Caused By The Genus Candida, The Diagnosis Should Be Confirmed By Koh Smears And/or Cultures.

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Cetyl Alcohol CETYL ALCOHOL Molecular
2. Isopropyl Myristate ISOPROPYL MYRISTATE Molecular
3. Polysorbate 60 POLYSORBATE 60 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , FEED-Feed additives , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
4. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
5. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
6. Stearyl Alcohol STEARYL ALCOHOL Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Terconazole TERCONAZOLE ZINC3873936

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