Last Updated: August 10, 2026

Details for New Drug Application (NDA): 205490

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NDA 205490 describes CETIRIZINE HYDROCHLORIDE ALLERGY, which is a drug marketed by Apotex, Aurobindo Pharma Ltd, Bionpharma, 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, Granules, Heritage Pharma, Marksans Pharma, Mylan, Orbion Pharms, Pld Acquisitions, Sun Pharm Inds Ltd, Taro, Torrent Pharms Llc, Unichem, and Unique, and is included in twenty-eight NDAs. It is available from one hundred and thirty-three suppliers. Additional details are available on the CETIRIZINE HYDROCHLORIDE ALLERGY profile page.

The generic ingredient in CETIRIZINE HYDROCHLORIDE ALLERGY is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and sixty-three suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.

Summary for 205490

Tradename:	CETIRIZINE HYDROCHLORIDE ALLERGY
Applicant:	Perrigo R And D
Ingredient:	cetirizine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 205490

Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	10MG
Approval Date:	Sep 2, 2015	TE:		RLD:	No

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