General MedicationsORALStandard
FLUCONAZOLE
FLUCONAZOLE
Standard Dose
50MG/5ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview FLUCONAZOLE is listed in Drugs@FDA under application 079150 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient FLUCONAZOLE Form and strength FOR SUSPENSION;ORAL - 50MG/5ML Sponsor AUROBINDO PHARMA Submission history Latest submission status date: 2024-07-16 00:00:00.
Structured Monograph
Clinical summary
Approval overview FLUCONAZOLE is listed in Drugs@FDA under application 079150 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient FLUCONAZOLE Form and strength FOR SUSPENSION;ORAL - 50MG/5ML Sponsor AUROBINDO PHARMA Submission history Latest submission status date: 2024-07-16 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.