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DEXMETHYLPHENIDATE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CEDIPROF INC · Approved 2018-09-19

Drug application

FDA Application #

ANDA209211

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

CEDIPROF INC

Manufacturer

Nivagen Pharmaceuticals, Inc.

First approval

2018-09-19

Source

Authoritative

Drugs@FDA application overview

Machine

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