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General MedicationsORALStandard

AMANTADINE HYDROCHLORIDE

AMANTADINE HYDROCHLORIDE

Standard Dose
100MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview AMANTADINE HYDROCHLORIDE is listed in Drugs@FDA under application 214580 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient AMANTADINE HYDROCHLORIDE Form and strength CAPSULE;ORAL - 100MG Sponsor HUMANWELL PURACAP Submission history Latest submission status date: 2025-07-10 00:00:00.

Structured Monograph

Clinical summary

Approval overview AMANTADINE HYDROCHLORIDE is listed in Drugs@FDA under application 214580 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient AMANTADINE HYDROCHLORIDE Form and strength CAPSULE;ORAL - 100MG Sponsor HUMANWELL PURACAP Submission history Latest submission status date: 2025-07-10 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.