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BUDESONIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN · Approved 2020-09-17

Drug application

FDA Application #

ANDA208851

Application type

Abbreviated New Drug Application (Generic)

Brand name

BUDESONIDE

Generic name

BUDESONIDE

Active ingredients

BUDESONIDE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

MYLAN

Manufacturer

Mylan Pharmaceuticals Inc.

First approval

2020-09-17

Source

Authoritative

Drugs@FDA application overview

Machine

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