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BUDESONIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: IMPAX LABS INC · Approved 2012-07-31

Drug application

FDA Application #

ANDA078404

Application type

Abbreviated New Drug Application (Generic)

Brand name

BUDESONIDE

Generic name

BUDESONIDE

Active ingredients

BUDESONIDE

Dosage form

SUSPENSION

Route

INHALATION

Marketing status

Prescription

Sponsor

IMPAX LABS INC

Manufacturer

Amneal Pharmaceuticals of New York LLC

First approval

2012-07-31

Source

Authoritative

Drugs@FDA application overview

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