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General MedicationsORALGeneric

RUZURGI

AMIFAMPRIDINE

Standard Dose
10MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: None (Tentative Approval)
Summary

Approval overview RUZURGI is listed in Drugs@FDA under application 209321 (NDA).

Review priority: PRIORITY Marketing status: None (Tentative Approval) Active ingredient AMIFAMPRIDINE Form and strength TABLET;ORAL - 10MG Sponsor JACOBUS PHARM CO INC Submission history Latest submission status date: 2022-02-01 00:00:00.

Structured Monograph

Clinical summary

Approval overview RUZURGI is listed in Drugs@FDA under application 209321 (NDA). Review priority: PRIORITY Marketing status: None (Tentative Approval) Active ingredient AMIFAMPRIDINE Form and strength TABLET;ORAL - 10MG Sponsor JACOBUS PHARM CO INC Submission history Latest submission status date: 2022-02-01 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.