Product manufactured by Proficient Rx Lp

Application Nr Approved Date Route Status External Links
ANDA077731 2008-10-07 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Fluconazole Tablets Usp Are Indicated For The Treatment Of: 1.vaginal Candidiasis (vaginal Yeast Infections Due To Candida). 2.oropharyngeal And Esophageal Candidiasis. In Open Noncomparative Studies Of Relatively Small Numbers Of Patients, Fluconazole Tablets Usp Were Also Effective For The Treatment Of Candida Urinary Tract Infections, Peritonitis, And Systemic Candida Infections Including Candidemia, Disseminated Candidiasis, And Pneumonia. 3. Cryptococcal Meningitis. Before Prescribing Fluconazole Tablets Usp For Aids Patients With Cryptococcal Meningitis, Please See Clinical Studies Section. Studies Comparing Fluconazole Tablets Usp To Amphotericin B In Non-Hiv Infected Patients Have Not Been Conducted. Prophylaxis. Fluconazole Tablets Usp 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 (4 Total)

Name Structure Kind Function Status
1. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
2. Calcium Phosphate, Dibasic, Anhydrous CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS Molecular
3. Povidones POVIDONES Unresolved
4. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved

Active Ingredients ( 1 Total)

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