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METADATE CD

NDA · New Drug Application · Sponsor: AYTU BIOPHARMA · Approved 2001-04-03

Drug application

FDA Application #

NDA021259

Application type

New Drug Application

Brand name

METADATE CD

Generic name

METHYLPHENIDATE HYDROCHLORIDE

Active ingredients

METHYLPHENIDATE HYDROCHLORIDE

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

AYTU BIOPHARMA

Manufacturer

Lannett Company, Inc.

First approval

2001-04-03

Source

Authoritative

Drugs@FDA application overview

Machine

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