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METHYLPHENIDATE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACTAVIS LABS FL · Approved 2018-03-22

Drug application

FDA Application #

ANDA076772

Application type

Abbreviated New Drug Application (Generic)

Brand name

METHYLPHENIDATE HYDROCHLORIDE

Generic name

METHYLPHENIDATE HYDROCHLORIDE

Active ingredients

METHYLPHENIDATE HYDROCHLORIDE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

ACTAVIS LABS FL

Manufacturer

Actavis Pharma, Inc.

First approval

2018-03-22

Source

Authoritative

Drugs@FDA application overview

Machine

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