General MedicationsORALStandard
FELBAMATE
FELBAMATE
Standard Dose
600MG/5ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview FELBAMATE is listed in Drugs@FDA under application 211333 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient FELBAMATE Form and strength SUSPENSION;ORAL - 600MG/5ML Sponsor NOVITIUM PHARMA Submission history Latest submission status date: 2019-05-31 00:00:00.
Structured Monograph
Clinical summary
Approval overview FELBAMATE is listed in Drugs@FDA under application 211333 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient FELBAMATE Form and strength SUSPENSION;ORAL - 600MG/5ML Sponsor NOVITIUM PHARMA Submission history Latest submission status date: 2019-05-31 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.