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BUDESONIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS · Approved 2017-05-04

Drug application

FDA Application #

ANDA206134

Application type

Abbreviated New Drug Application (Generic)

Brand name

BUDESONIDE

Generic name

BUDESONIDE

Active ingredients

BUDESONIDE

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

ZYDUS PHARMS

Manufacturer

Zydus Pharmaceuticals USA Inc.

First approval

2017-05-04

Source

Authoritative

Drugs@FDA application overview

Machine

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