General MedicationsORALStandard

SAFINAMIDE MESYLATE

Standard Dose

EQ 100MG BASE

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview SAFINAMIDE MESYLATE is listed in Drugs@FDA under application 215978 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient SAFINAMIDE MESYLATE Form and strength TABLET;ORAL - EQ 100MG BASE Sponsor MSN Submission history Latest submission status date: 2024-12-31 00:00:00.

Structured Monograph

Clinical summary

Approval overview SAFINAMIDE MESYLATE is listed in Drugs@FDA under application 215978 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient SAFINAMIDE MESYLATE Form and strength TABLET;ORAL - EQ 100MG BASE Sponsor MSN Submission history Latest submission status date: 2024-12-31 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.