← FDA DRUG APPROVALS

FDA NDA · NDA213801

MYRBETRIQ

mirabegron

Sponsor: APGDI

APPLICATION
NDA213801
TYPE
NDA
ORIGINAL APPROVAL
2021-03-25
LATEST ACTION
2021-03-25
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

MYRBETRIQ GRANULES · ReferencePrescription
MIRABEGRON 8MG/ML · FOR SUSPENSION, EXTENDED RELEASE · ORAL

Approval history

2021-03-25Type 3 - New Dosage Form · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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