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PAROXETINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CSPC OUYI · Approved 2021-02-16

Drug application

FDA Application #

ANDA213485

Application type

Abbreviated New Drug Application (Generic)

Brand name

PAROXETINE HYDROCHLORIDE

Generic name

PAROXETINE

Active ingredients

PAROXETINE HYDROCHLORIDE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

CSPC OUYI

Manufacturer

Westminster Pharmaceuticals, LLC

First approval

2021-02-16

Source

Authoritative

Drugs@FDA application overview

Machine

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