General MedicationsORALStandard
DALFAMPRIDINE
DALFAMPRIDINE
Standard Dose
10MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview DALFAMPRIDINE is listed in Drugs@FDA under application 210158 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient DALFAMPRIDINE Form and strength TABLET, EXTENDED RELEASE;ORAL - 10MG Sponsor MICRO LABS Submission history Latest submission status date: 2023-04-11 00:00:00.
Structured Monograph
Clinical summary
Approval overview DALFAMPRIDINE is listed in Drugs@FDA under application 210158 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DALFAMPRIDINE Form and strength TABLET, EXTENDED RELEASE;ORAL - 10MG Sponsor MICRO LABS Submission history Latest submission status date: 2023-04-11 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.