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CETIRIZINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: RUBICON RESEARCH · Approved 2026-02-25

Drug application

FDA Application #

ANDA220335

Application type

Abbreviated New Drug Application (Generic)

Brand name

CETIRIZINE HYDROCHLORIDE

Generic name

CETIRIZINE HYDROCHLORIDE

Active ingredients

CETIRIZINE HYDROCHLORIDE

Dosage form

SOLUTION

Route

ORAL

Marketing status

Prescription

Sponsor

RUBICON RESEARCH

Manufacturer

Advagen Pharma Ltd.,

First approval

2026-02-25

Source

Authoritative

Drugs@FDA application overview

Machine

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