Application Nr Approved Date Route Status External Links
ANDA075319 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Ketoconazole Tablets Are Not Indicated For Treatment Of Onychomycosis, Cutaneous Dermatophyte Infections, Or Candida Infections. Ketoconazole Tablets Should Be Used Only When Other Effective Antifungal Therapy Is Not Available Or Tolerated And The Potential Benefits Are Considered To Outweigh The Potential Risks. Ketoconazole Tablets Are Indicated For The Treatment Of The Following Systemic Fungal Infections In Patients Who Have Failed Or Who Are Intolerant To Other Therapies: Blastomycosis, Coccidioidomycosis, Histoplasmosis, Chromomycosis, And Paracoccidioidomycosis. Ketoconazole Tablets Should Not Be Used For Fungal Meningitis Because It Penetrates Poorly Into The Cerebrospinal Fluid.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ketoconazole KETOCONAZOLE ZINC643153

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