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FDA NDA · NDA202611

MYRBETRIQ

mirabegron

Sponsor: APGDI

APPLICATION
NDA202611
TYPE
NDA
ORIGINAL APPROVAL
2012-06-28
LATEST ACTION
2021-03-25
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

MYRBETRIQ · ReferencePrescription
MIRABEGRON 25MG · TABLET, EXTENDED RELEASE · ORAL
MYRBETRIQ · ReferencePrescription
MIRABEGRON 50MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2021-03-25Efficacy · Supplement 17 · priority — Label ↗AP
2018-04-27Efficacy · Supplement 11 · standard — Letter ↗AP
2017-07-28Labeling · Supplement 12 · standard — Label ↗AP
2016-08-16Labeling · Supplement 7 · standard — Label ↗AP
2016-08-01Manufacturing (CMC) · Supplement 8 · standardAP
2015-11-02Labeling · Supplement 5 · standard — Label ↗AP
2015-08-10Labeling · Supplement 6 · standard — Letter ↗AP
2015-02-09Manufacturing (CMC) · Supplement 4 · standardAP
2014-03-13Manufacturing (CMC) · Supplement 3 · standardAP
2013-07-19Manufacturing (CMC) · Supplement 2 · standardAP
2013-03-04Manufacturing (CMC) · Supplement 1 · standardAP
2012-06-28Type 1 - New Molecular Entity · Original · standard — Label ↗AP
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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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