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METHYLIN

NDA · New Drug Application · Sponsor: SPECGX LLC · Approved 2002-12-19

Drug application

FDA Application #

NDA021419

Application type

New Drug Application

Brand name

METHYLIN

Generic name

METHYLPHENIDATE HYDROCHLORIDE

Active ingredients

METHYLPHENIDATE HYDROCHLORIDE

Dosage form

SOLUTION

Route

ORAL

Marketing status

Prescription

Sponsor

SPECGX LLC

Manufacturer

SHIONOGI INC.

First approval

2002-12-19

Source

Authoritative

Drugs@FDA application overview

Machine

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