General MedicationsORALStandard
MYHIBBIN
MYCOPHENOLATE MOFETIL
Standard Dose
200MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview MYHIBBIN is listed in Drugs@FDA under application 216482 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient MYCOPHENOLATE MOFETIL Form and strength SUSPENSION;ORAL - 200MG/ML Sponsor AZURITY Submission history Latest submission status date: 2025-06-27 00:00:00.
Structured Monograph
Clinical summary
Approval overview MYHIBBIN is listed in Drugs@FDA under application 216482 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient MYCOPHENOLATE MOFETIL Form and strength SUSPENSION;ORAL - 200MG/ML Sponsor AZURITY Submission history Latest submission status date: 2025-06-27 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.