Application Nr Approved Date Route Status External Links
ANDA076077 2004-07-29 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Fluconazole Tablets Are Indicated For The Treatment Of: Vaginal Candidiasis (vaginal Yeast Infections Due To Candida). Oropharyngeal And Esophageal Candidiasis. In Open Noncomparative Studies Of Relatively Small Numbers Of Patients, Fluconazole Was Also Effective For The Treatment Of Candida Urinary Tract Infections, Peritonitis, And Systemic Candida Infections Including Candidemia, Disseminated Candidiasis, And Pneumonia. Cryptococcal Meningitis. Before Prescribing Fluconazole For Aids Patients With Cryptococcal Meningitis, Please See Clinical Studies. Studies Comparing Fluconazole To Amphotericin B In Non-Hiv Infected Patients Have Not Been Conducted. Prophylaxis Fluconazole Tablets Are Also Indicated To Decrease The Incidence Of Candidiasis In Patients Undergoing Bone Marrow Transplantation Who Receive Cytotoxic Chemotherapy And/or Radiation Therapy. Specimens For Fungal Culture And Other Relevant Laboratory Studies (serology, Histopathology) Should Be Obtained Prior To Therapy To Isolate And Identify Causative Organisms. Therapy May Be Instituted Before The Results Of The Cultures And Other Laboratory Studies Are Known; However, Once These Results Become Available, Anti-Infective Therapy Should Be Adjusted Accordingly

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Starch, Corn STARCH, CORN Unresolved
3. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
4. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
5. 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.
6. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Fluconazole FLUCONAZOLE ZINC4009

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