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ORTIKOS

NDA · New Drug Application · Sponsor: SUN PHARM INDS INC · Approved 2019-06-13

Drug application

FDA Application #

NDA211929

Application type

New Drug Application

Brand name

ORTIKOS

Generic name

Budesonide

Active ingredients

BUDESONIDE

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

Marketing status

Discontinued

Sponsor

SUN PHARM INDS INC

First approval

2019-06-13

Source

Authoritative

Drugs@FDA application overview

Machine

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