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HYDROXYZINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PAI HOLDINGS PHARM · Approved 2002-04-10

Drug application

FDA Application #

ANDA040391

Application type

Abbreviated New Drug Application (Generic)

Brand name

HYDROXYZINE HYDROCHLORIDE

Generic name

HYDROXYZINE HYDROCHLORIDE

Active ingredients

HYDROXYZINE HYDROCHLORIDE

Dosage form

SYRUP

Route

ORAL

Marketing status

Prescription

Sponsor

PAI HOLDINGS PHARM

Manufacturer

PAI Holdings, LLC dba PAI Pharma

First approval

2002-04-10

Source

Authoritative

Drugs@FDA application overview

Machine

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