General MedicationsORALStandard
BAFIERTAM
MONOMETHYL FUMARATE
Standard Dose
95MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview BAFIERTAM is listed in Drugs@FDA under application 210296 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient MONOMETHYL FUMARATE Form and strength CAPSULE, DELAYED RELEASE;ORAL - 95MG Sponsor BANNER LIFE SCIENCES Submission history Latest submission status date: 2024-09-26 00:00:00.
Structured Monograph
Clinical summary
Approval overview BAFIERTAM is listed in Drugs@FDA under application 210296 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient MONOMETHYL FUMARATE Form and strength CAPSULE, DELAYED RELEASE;ORAL - 95MG Sponsor BANNER LIFE SCIENCES Submission history Latest submission status date: 2024-09-26 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.