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BUDESONIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TEVA PHARMS USA · Approved 2016-03-08

Drug application

FDA Application #

ANDA204548

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

TEVA PHARMS USA

Manufacturer

Teva Pharmaceuticals USA, Inc.

First approval

2016-03-08

Source

Authoritative

Drugs@FDA application overview

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