Application Nr Approved Date Route Status External Links
ANDA075319 1999-06-15 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Ketoconazole Tablets Usp, 200 Mg 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 Usp, 200 Mg 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 Usp, 200 Mg Should Not Be Used For Fungal Meningitis Because It Penetrates Poorly Into The Cerebrospinal Fluid.

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Starch, Corn STARCH, CORN Unresolved
2. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
3. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved

Active Ingredients ( 1 Total)

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