← FDA Drug Approvals (Drugs@FDA)

MIRABEGRON

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2026-01-20

Drug application

FDA Application #

ANDA219323

Application type

Abbreviated New Drug Application (Generic)

Brand name

MIRABEGRON

Generic name

Mirabegron

Active ingredients

MIRABEGRON

Dosage form

FOR SUSPENSION, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

ALKEM LABS LTD

First approval

2026-01-20

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown