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General MedicationsORALGeneric

SAFINAMIDE

SAFINAMIDE

Standard Dose
50MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary

Approval overview SAFINAMIDE is listed in Drugs@FDA under application 216020 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient SAFINAMIDE Form and strength TABLET;ORAL - 50MG Sponsor OPTIMUS PHARMA PRIVATE LTD Submission history Latest submission status date: 2023-01-12 00:00:00.

Structured Monograph

Clinical summary

Approval overview SAFINAMIDE is listed in Drugs@FDA under application 216020 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient SAFINAMIDE Form and strength TABLET;ORAL - 50MG Sponsor OPTIMUS PHARMA PRIVATE LTD Submission history Latest submission status date: 2023-01-12 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: None (Tentative Approval)
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
SAFINAMIDE (SAFINAMIDE) | Drug Monograph | MedicHelpline