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DEXMETHYLPHENIDATE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVEL LABS INC · Approved 2015-12-04

Drug application

FDA Application #

ANDA204534

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

NOVEL LABS INC

Manufacturer

Lupin Pharmaceuticals,Inc.

First approval

2015-12-04

Source

Authoritative

Drugs@FDA application overview

Machine

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