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ARISTADA INITIO KIT

NDA · New Drug Application · Sponsor: ALKERMES INC · Approved 2018-06-29

Drug application

FDA Application #

NDA209830

Application type

New Drug Application

Brand name

ARISTADA INITIO KIT

Generic name

ARIPIPRAZOLE LAUROXIL

Active ingredients

ARIPIPRAZOLE LAUROXIL

Dosage form

SUSPENSION, EXTENDED RELEASE

Route

INTRAMUSCULAR

Marketing status

Prescription

Sponsor

ALKERMES INC

Manufacturer

Alkermes, Inc.

First approval

2018-06-29

Source

Authoritative

Drugs@FDA application overview

Machine

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