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MITIGARE

NDA · New Drug Application · Sponsor: HIKMA INTL PHARMS · Approved 2014-09-26

Drug application

FDA Application #

NDA204820

Application type

New Drug Application

Brand name

MITIGARE

Generic name

COLCHICINE

Active ingredients

COLCHICINE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

HIKMA INTL PHARMS

Manufacturer

Hikma Specialty USA Inc.

First approval

2014-09-26

Source

Authoritative

Drugs@FDA application overview

Machine

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