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General MedicationsORALStandard

MEMANTINE HYDROCHLORIDE

MEMANTINE HYDROCHLORIDE

Standard Dose
2MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview MEMANTINE HYDROCHLORIDE is listed in Drugs@FDA under application 210319 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient MEMANTINE HYDROCHLORIDE Form and strength SOLUTION;ORAL - 2MG/ML Sponsor SETON PHARMS Submission history Latest submission status date: 2020-08-31 00:00:00.

Structured Monograph

Clinical summary

Approval overview MEMANTINE HYDROCHLORIDE is listed in Drugs@FDA under application 210319 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient MEMANTINE HYDROCHLORIDE Form and strength SOLUTION;ORAL - 2MG/ML Sponsor SETON PHARMS Submission history Latest submission status date: 2020-08-31 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.