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General MedicationsORALGeneric

OSMOLEX ER

AMANTADINE HYDROCHLORIDE

Standard Dose
EQ 161MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview OSMOLEX ER is listed in Drugs@FDA under application 209410 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient AMANTADINE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - EQ 161MG BASE Sponsor SUPERNUS PHARMS Submission history Latest submission status date: 2025-07-10 00:00:00.

Structured Monograph

Clinical summary

Approval overview OSMOLEX ER is listed in Drugs@FDA under application 209410 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient AMANTADINE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - EQ 161MG BASE Sponsor SUPERNUS PHARMS Submission history Latest submission status date: 2025-07-10 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.