Application Nr Approved Date Route Status External Links
ANDA073508 None Vaginal None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Miconazole Nitrate Vaginal Suppositories Usp, 200 Mg Are Indicated For The Local Treatment Of Vulvovaginal Candidiasis (Moniliasis). Effectiveness In Pregnancy Has Not Been Established. As Miconazole Nitrate Is Effective Only For Candidal Vulvovaginitis, The Diagnosis Should Be Confirmed By Koh Smear And/or Cultures. Other Pathogens Commonly Associated With Vulvovaginitis ( Trichomonas And Haemophilus Vaginalis [Gardnerella] ) Should Be Ruled Out By Appropriate Laboratory Methods.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Miconazole Nitrate MICONAZOLE NITRATE ZINC607971

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