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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 213557

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NDA 213557 describes CETIRIZINE HYDROCHLORIDE, which is a drug marketed by Actavis Mid Atlantic, Amneal Pharms, Apozeal Pharms, Aurobindo Pharma Ltd, Bajaj, Bionpharma, Chartwell Molecular, Lannett Co Inc, Padagis Us, Pharm Assoc, Ranbaxy Labs Ltd, Taro, Teva Pharms, Wockhardt, Regcon Holdings, Apotex, Catalent, Onesource Specialty, Sun Pharm Inds Inc, Perrigo R And D, Aiping Pharm Inc, Amneal Pharms Ny, Apotex Inc, Cipla Ltd, Contract Pharmacal, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Granules, Heritage Pharma, Marksans Pharma, Mylan, Orbion Pharms, Pld Acquisitions, Sun Pharm Inds Ltd, Torrent Pharms Llc, Unichem, Unique, Ivax Sub Teva Pharms, and Ppi-dac, and is included in fifty NDAs. It is available from twenty-one suppliers. Additional details are available on the CETIRIZINE HYDROCHLORIDE profile page.

The generic ingredient in CETIRIZINE HYDROCHLORIDE is cetirizine hydrochloride; pseudoephedrine hydrochloride. There are thirty-nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.

Summary for 213557

Tradename:	CETIRIZINE HYDROCHLORIDE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	cetirizine hydrochloride
Patents:	0

Pharmacology for NDA: 213557

Mechanism of Action	Histamine H1 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 213557

Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating

Suppliers and Packaging for NDA: 213557

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CETIRIZINE HYDROCHLORIDE	cetirizine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	213557	ANDA	WALGREEN CO.	0363-0471	0363-0471-76	4 BLISTER PACK in 1 CARTON (0363-0471-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
CETIRIZINE HYDROCHLORIDE	cetirizine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	213557	ANDA	WALGREEN CO.	0363-4025	0363-4025-76	4 BLISTER PACK in 1 CARTON (0363-4025-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	10MG
Approval Date:	Sep 11, 2020	TE:		RLD:	No

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