Last Updated: September 25, 2026

Details for New Drug Application (NDA): 078412

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NDA 078412 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, Rubicon Research, Taro, Teva Pharms, Time Cap Labs, Regcon Holdings, Apotex, Catalent, Onesource, 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, Torrent Pharms Llc, Unichem, Unique, Ivax Sub Teva Pharms, and Ppi-dac, and is included in fifty-one NDAs. It is available from twenty-two suppliers. Additional details are available on the CETIRIZINE HYDROCHLORIDE profile page.

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

Summary for 078412

Tradename:	CETIRIZINE HYDROCHLORIDE
Applicant:	Pharm Assoc
Ingredient:	cetirizine hydrochloride
Patents:	0

Pharmacology for NDA: 078412

Mechanism of Action	Histamine H1 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 078412

Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating

Suppliers and Packaging for NDA: 078412

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CETIRIZINE HYDROCHLORIDE	cetirizine hydrochloride	SOLUTION;ORAL	078412	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-0874	0121-0874-04	120 mL in 1 BOTTLE (0121-0874-04)
CETIRIZINE HYDROCHLORIDE	cetirizine hydrochloride	SOLUTION;ORAL	078412	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-0874	0121-0874-16	480 mL in 1 BOTTLE (0121-0874-16)

Profile for product number 001

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

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