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MIRABEGRON

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS · Approved 2022-09-29

Drug application

FDA Application #

ANDA209488

Application type

Abbreviated New Drug Application (Generic)

Brand name

MIRABEGRON

Generic name

MIRABEGRON

Active ingredients

MIRABEGRON

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

ZYDUS PHARMS

Manufacturer

Zydus Pharmaceuticals (USA) Inc.

First approval

2022-09-29

Source

Authoritative

Drugs@FDA application overview

Machine

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