Application Nr Approved Date Route Status External Links
ANDA211786 None Vaginal None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Metronidazole Vaginal Gel Is Indicated In The Treatment Of Bacterial Vaginosis (formerly Referred To As Haemophilus Vaginitis, Gardnerella Vaginitis, Nonspecific Vaginitis, Corynebacterium Vaginitis, Or Anaerobic Vaginosis). Note: For Purposes Of This Indication, A Clinical Diagnosis Of Bacterial Vaginosis Is Usually Defined By The Presence Of A Homogeneous Vaginal Discharge That (a) Has A Ph Of Greater Than 4.5, (b) Emits A "fishy" Amine Odor When Mixed With A 10% Koh Solution, And (c) Contains Clue Cells On Microscopic Examination. Gram's Stain Results Consistent With A Diagnosis Of Bacterial Vaginosis Include (a) Markedly Reduced Or Absent Lactobacillus Morphology, (b) Predominance Of Gardnerella Morphotype, And (c) Absent Or Few White Blood Cells. Other Pathogens Commonly Associated With Vulvovaginitis, E.g., Trichomonas Vaginalis , Chlamydia Trachomatis , N. Gonorrhoeae , Candida Albicans , And Herpes Simplex Virus Should Be Ruled Out.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Metronidazole METRONIDAZOLE ZINC113442

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