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Last Updated: December 14, 2024

Details for New Drug Application (NDA): 077472

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NDA 077472 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, Indoco, Apotex, Catalent, Strides Pharma, Sun Pharm Inds Inc, Perrigo R And D, Amneal Pharms Ny, Apotex Inc, Cipla Ltd, Contract Pharmacal, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Granules, Heritage Pharma, Ipca Labs Ltd, 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 seventeen 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-six suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.

Summary for 077472

Tradename:	CETIRIZINE HYDROCHLORIDE
Applicant:	Ranbaxy Labs Ltd
Ingredient:	cetirizine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 077472

Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	5MG/5ML
Approval Date:	Jun 18, 2008	TE:		RLD:	No

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