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CASODEX

NDA · New Drug Application · Sponsor: ANI PHARMS · Approved 1995-10-04

Drug application

FDA Application #

NDA020498

Application type

New Drug Application

Brand name

CASODEX

Generic name

BICALUTAMIDE

Active ingredients

BICALUTAMIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ANI PHARMS

Manufacturer

ANI Pharmaceuticals, Inc.

First approval

1995-10-04

Source

Authoritative

Drugs@FDA application overview

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