Application Nr Approved Date Route Status External Links
NDA050680 None Vaginal None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Clindamycin Phosphate Vaginal Cream 2%, Is Indicated In The Treatment Of Bacterial Vaginosis (Formerly Referred To As Haemophilus Vaginitis, Gardnerella Vaginitis, Nonspecific Vaginitis, Corynebacterium Vaginitis, Or Anaerobic Vaginosis). Clindamycin Phosphate Vaginal Cream 2%, Can Be Used To Treat Non-Pregnant Women And Pregnant Women During The Second And Third Trimester. (See Clinical Studies .) 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, Eg, 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. Clindamycin Phosphate

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