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General MedicationsTABLET, EXTENDED RELEASEGeneric

MIRABEGRON

MIRABEGRON

Standard Dose
25MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary

Approval overview MIRABEGRON is listed in Drugs@FDA under application 216757 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient MIRABEGRON Form and strength TABLET, EXTENDED RELEASE - 25MG Sponsor SUNSHINE LAKE PHARMA CO LTD Submission history Latest submission status date: 2025-12-10 00:00:00.

Structured Monograph

Clinical summary

Approval overview MIRABEGRON is listed in Drugs@FDA under application 216757 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient MIRABEGRON Form and strength TABLET, EXTENDED RELEASE - 25MG Sponsor SUNSHINE LAKE PHARMA CO LTD Submission history Latest submission status date: 2025-12-10 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.