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General MedicationsORALStandard

TOPIRAMATE

TOPIRAMATE

Standard Dose
25MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: UNKNOWN Marketing status: Prescription
Summary

Approval overview TOPIRAMATE is listed in Drugs@FDA under application 217795 (ANDA).

Review priority: UNKNOWN Marketing status: Prescription Active ingredient TOPIRAMATE Form and strength SOLUTION;ORAL - 25MG/ML Sponsor ALKEM LABS LTD Submission history Latest submission status date: 2025-02-26 00:00:00.

Structured Monograph

Clinical summary

Approval overview TOPIRAMATE is listed in Drugs@FDA under application 217795 (ANDA). Review priority: UNKNOWN Marketing status: Prescription Active ingredient TOPIRAMATE Form and strength SOLUTION;ORAL - 25MG/ML Sponsor ALKEM LABS LTD Submission history Latest submission status date: 2025-02-26 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: UNKNOWN

Interaction Notes

  • No interaction notes stored yet.