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BREYNA

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN · Approved 2022-03-15

Drug application

FDA Application #

ANDA211699

Application type

Abbreviated New Drug Application (Generic)

Brand name

BREYNA

Generic name

BUDESONIDE AND FORMOTEROL FUMARATE

Active ingredients

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

Dosage form

AEROSOL, METERED

Route

INHALATION

Marketing status

Prescription

Sponsor

MYLAN

Manufacturer

Mylan Pharmaceuticals Inc.

First approval

2022-03-15

Source

Authoritative

Drugs@FDA application overview

Machine

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