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DEXMETHYLPHENIDATE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TRIS PHARMA INC · Approved 2016-08-26

Drug application

FDA Application #

ANDA207901

Application type

Abbreviated New Drug Application (Generic)

Brand name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Generic name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Active ingredients

DEXMETHYLPHENIDATE HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

TRIS PHARMA INC

Manufacturer

Cranbury Pharmaceuticals, LLC

First approval

2016-08-26

Source

Authoritative

Drugs@FDA application overview

Machine

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