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CHILDREN'S ZYRTEC HIVES

NDA

CETIRIZINE HYDROCHLORIDE | N022155 | KENVUE BRANDS LLC

2 strengths0 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain10 active DMFs3 inactive

10 active API suppliers hold Drug Master Files for this ingredient.

UCB PHARMA SACETIRIZINE HYDROCHLORIDE

DMF 68531987

UCB FARCHIM SACETIRIZINE HYDROCHLORIDE

DMF 175132004

MATRIX PHARMACORP PRIVATE LTDCETIRIZINE HYDROCHLORIDE USP

DMF 177412004

SOLARA ACTIVE PHARMA SCIENCES LTDCETIRIZINE HYDROCHLORIDE DIHYDROCHLORIDE USP

DMF 205392007

CALYX CHEMICALS AND PHARMACEUTICALS LTDCETIRIZINE HYDROCHLORIDE

DMF 213962008

CIMA LABORATORIES INCCETIRIZINE HYDROCHLORIDE COATED GRANULES

DMF 226802009

IPCA LABORATORIES LTDCETIRIZINE HYDROCHLORIDE USP (CZ5 PROCESS)

DMF 260332012

UNICHEM LABORATORIES LTDCETIRIZINE HYDROCHLORIDE USP

DMF 280592014

THINQ PHARMA-CRO LTDCETIRIZINE HYDROCHLORIDE USP

DMF 288872015

SUPRIYA LIFESCIENCE LTDCETIRIZINE HYDROCHLORIDE USP

DMF 391992024

IPCA LABORATORIES LTDInactiveCETIRIZINE HYDROCHLORIDE USP

DMF 209972007

IWAKI SEIYAKU CO LTDInactiveCETIRIZINE HYDROCHLORIDE

DMF 218642008

DISHMAN CARBOGEN AMCIS LTDInactiveCETIRIZINE HYDROCHLORIDE

DMF 261792012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Dec 31, 2025	SUPPL -29	View Letter (PDF)
Jan 21, 2025	SUPPL -25	View Letter (PDF)
Nov 29, 2024	SUPPL -27	View Letter (PDF)
Oct 15, 2018	SUPPL -15	View Letter (PDF)
Apr 18, 2016	SUPPL -10	View Letter (PDF)
May 20, 2014	SUPPL -9	View Letter (PDF)
May 24, 2012	SUPPL -7	View Letter (PDF)
Mar 17, 2009	SUPPL -6	View Letter (PDF)
Mar 5, 2009	SUPPL -5	View Letter (PDF)
Aug 19, 2008	SUPPL -3	View Letter (PDF)
Aug 19, 2008	SUPPL -2	View Letter (PDF)
Nov 26, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#002 — 5MG/5ML

RLD

0 patents0 exclusivities▾

SOLUTION;ORAL | Approved: Nov 16, 2007

#001 — 5MG/5ML

RLD

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Nov 16, 2007

No patent or exclusivity listings for this strength.