General MedicationsORALStandard
RUFINAMIDE
RUFINAMIDE
Standard Dose
40MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview RUFINAMIDE is listed in Drugs@FDA under application 216841 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient RUFINAMIDE Form and strength SUSPENSION;ORAL - 40MG/ML Sponsor HETERO LABS LTD III Submission history Latest submission status date: 2023-12-05 00:00:00.
Structured Monograph
Clinical summary
Approval overview RUFINAMIDE is listed in Drugs@FDA under application 216841 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient RUFINAMIDE Form and strength SUSPENSION;ORAL - 40MG/ML Sponsor HETERO LABS LTD III Submission history Latest submission status date: 2023-12-05 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.