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PAROXETINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: LUPIN · Approved 2017-01-20

Drug application

FDA Application #

ANDA204134

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

LUPIN

Manufacturer

Lupin Pharmaceuticals, Inc.

First approval

2017-01-20

Source

Authoritative

Drugs@FDA application overview

Machine

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