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General MedicationsORALGeneric

AMANTADINE

AMANTADINE

Standard Dose
137MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary

Approval overview AMANTADINE is listed in Drugs@FDA under application 214897 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient AMANTADINE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 137MG Sponsor ZYDUS Submission history Latest submission status date: 2024-08-26 00:00:00.

Structured Monograph

Clinical summary

Approval overview AMANTADINE is listed in Drugs@FDA under application 214897 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient AMANTADINE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 137MG Sponsor ZYDUS Submission history Latest submission status date: 2024-08-26 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

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