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MYRBETRIQ GRANULES

NDA · New Drug Application · Sponsor: APGDI · Approved 2021-03-25

Drug application

FDA Application #

NDA213801

Application type

New Drug Application

Brand name

MYRBETRIQ GRANULES

Generic name

MIRABEGRON

Active ingredients

MIRABEGRON

Dosage form

FOR SUSPENSION, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

APGDI

Manufacturer

Astellas Pharma US, Inc.

First approval

2021-03-25

Source

Authoritative

Drugs@FDA application overview

Machine

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