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BUDESONIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: LUPIN · Approved 2018-11-09

Drug application

FDA Application #

ANDA210897

Application type

Abbreviated New Drug Application (Generic)

Brand name

BUDESONIDE

Generic name

BUDESONIDE INHALATION

Active ingredients

BUDESONIDE

Dosage form

SUSPENSION

Route

INHALATION

Marketing status

Prescription

Sponsor

LUPIN

Manufacturer

Lupin Pharmaceuticals, Inc.

First approval

2018-11-09

Source

Authoritative

Drugs@FDA application overview

Machine

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