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Last Updated: April 3, 2026

Details for New Drug Application (NDA): 078398

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NDA 078398 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 078398

Tradename:	CETIRIZINE HYDROCHLORIDE
Applicant:	Padagis Us
Ingredient:	cetirizine hydrochloride
Patents:	0

Pharmacology for NDA: 078398

Mechanism of Action	Histamine H1 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 078398

Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating

Suppliers and Packaging for NDA: 078398

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CETIRIZINE HYDROCHLORIDE	cetirizine hydrochloride	SOLUTION;ORAL	078398	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-626	45802-626-26	1 BOTTLE in 1 CARTON (45802-626-26) / 120 mL in 1 BOTTLE
CETIRIZINE HYDROCHLORIDE	cetirizine hydrochloride	SOLUTION;ORAL	078398	ANDA	Preferred Pharmaceuticals Inc.	68788-8523	68788-8523-1	1 BOTTLE in 1 CARTON (68788-8523-1) / 120 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	5MG/5ML
Approval Date:	Jun 17, 2008	TE:	AA	RLD:	No

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