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ZYRTEC-D 12 HOUR

NDA · New Drug Application · Sponsor: KENVUE BRANDS · Approved 2001-08-10

Drug application

FDA Application #

NDA021150

Application type

New Drug Application

Brand name

ZYRTEC-D 12 HOUR

Generic name

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Active ingredients

CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Over-the-counter

Sponsor

KENVUE BRANDS

Manufacturer

Kenvue Brands LLC

First approval

2001-08-10

Source

Authoritative

Drugs@FDA application overview

Machine

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