Last Updated: June 25, 2026

Details for New Drug Application (NDA): 218895

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NDA 218895 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 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, 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 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 218895

Tradename:	CETIRIZINE HYDROCHLORIDE
Applicant:	Regcon Holdings
Ingredient:	cetirizine hydrochloride
Patents:	0

Pharmacology for NDA: 218895

Mechanism of Action	Histamine H1 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 218895

Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating

Suppliers and Packaging for NDA: 218895

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CETIRIZINE HYDROCHLORIDE	cetirizine hydrochloride	TABLET;ORAL	218895	ANDA	Indoco Remedies Limited	14445-152	14445-152-01	1 BOTTLE in 1 CARTON (14445-152-01) / 100 TABLET, FILM COATED in 1 BOTTLE
CETIRIZINE HYDROCHLORIDE	cetirizine hydrochloride	TABLET;ORAL	218895	ANDA	Indoco Remedies Limited	14445-152	14445-152-03	1 BOTTLE in 1 CARTON (14445-152-03) / 300 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Oct 3, 2024	TE:		RLD:	No

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