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CONCERTA

NDA · New Drug Application · Sponsor: JANSSEN PHARMS · Approved 2000-08-01

Drug application

FDA Application #

NDA021121

Application type

New Drug Application

Brand name

CONCERTA

Generic name

METHYLPHENIDATE HYDROCHLORIDE

Active ingredients

METHYLPHENIDATE HYDROCHLORIDE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

JANSSEN PHARMS

Manufacturer

Janssen Pharmaceuticals, Inc.

First approval

2000-08-01

Source

Authoritative

Drugs@FDA application overview

Machine

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