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ACTIGALL

NDA · New Drug Application · Sponsor: TEVA BRANDED PHARM · Approved 1987-12-31

Drug application

FDA Application #

NDA019594

Application type

New Drug Application

Brand name

ACTIGALL

Generic name

URSODIOL

Active ingredients

URSODIOL

Dosage form

CAPSULE

Route

ORAL

Marketing status

Discontinued

Sponsor

TEVA BRANDED PHARM

Manufacturer

Actavis Pharma, Inc.

First approval

1987-12-31

Source

Authoritative

Drugs@FDA application overview

Machine

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