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ZYRTEC-D 12 HOUR

NDA

CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | N021150 | KENVUE BRANDS LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Strides Inc. FDA-2006-P-0286 · 4 docket documents Strides Inc. filed a citizen petition regarding cetirizine hydrochloride products, specifically referencing Orange Book data for Pfizer's Zyrtec formulations across multiple dosage forms and strengths including tablets, chewable tablets, and syrup, as well as the combination product Zyrtec-D 12 Hour	Other	2009-04-20	Denied	Strides Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Jul 6, 2026	SUPPL -25	View Letter (PDF)
Sep 16, 2024	SUPPL -22	View Letter (PDF)
Nov 5, 2021	SUPPL -21	View Letter (PDF)
Nov 13, 2007	SUPPL -7	View Letter (PDF)
Mar 24, 2004	SUPPL -5	View Letter (PDF)
May 29, 2003	SUPPL -2	View Letter (PDF)
Aug 10, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#002 — 5MG;120MG

RLD

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Nov 9, 2007

No patent or exclusivity listings for this strength.