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PAROXETINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN · Approved 2008-03-13

Drug application

FDA Application #

ANDA078902

Application type

Abbreviated New Drug Application (Generic)

Brand name

PAROXETINE HYDROCHLORIDE

Generic name

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Active ingredients

PAROXETINE HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

MYLAN

Manufacturer

Mylan Pharmaceuticals Inc.

First approval

2008-03-13

Source

Authoritative

Drugs@FDA application overview

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