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General MedicationsORALStandard

MIRABEGRON

MIRABEGRON

Standard Dose
8MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview MIRABEGRON is listed in Drugs@FDA under application 219323 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient MIRABEGRON Form and strength FOR SUSPENSION, EXTENDED RELEASE;ORAL - 8MG/ML Sponsor ALKEM LABS LTD Submission history Latest submission status date: 2026-01-20 00:00:00.

Structured Monograph

Clinical summary

Approval overview MIRABEGRON is listed in Drugs@FDA under application 219323 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient MIRABEGRON Form and strength FOR SUSPENSION, EXTENDED RELEASE;ORAL - 8MG/ML Sponsor ALKEM LABS LTD Submission history Latest submission status date: 2026-01-20 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.