APPLICATION
ANDA218543
TYPE
ANDA
ORIGINAL APPROVAL
2025-11-04
LATEST ACTION
2025-11-04
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
MIRABEGRONPrescription
MIRABEGRON 25MG · TABLET, EXTENDED RELEASE · ORAL
MIRABEGRONPrescription
MIRABEGRON 50MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-11-04UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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