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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 207235


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NDA 207235 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 Inc, 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 suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 207235
Tradename:CETIRIZINE HYDROCHLORIDE ALLERGY
Applicant:Apotex
Ingredient:cetirizine hydrochloride
Patents:0
Pharmacology for NDA: 207235
Mechanism of ActionHistamine H1 Receptor Antagonists
Medical Subject Heading (MeSH) Categories for 207235
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Suppliers and Packaging for NDA: 207235
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride CAPSULE;ORAL 207235 ANDA Topco Associates LLC 36800-180 36800-180-09 1 BOTTLE in 1 PACKAGE (36800-180-09) / 65 CAPSULE, LIQUID FILLED in 1 BOTTLE
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride CAPSULE;ORAL 207235 ANDA Topco Associates LLC 36800-180 36800-180-63 1 BOTTLE in 1 PACKAGE (36800-180-63) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength10MG
Approval Date:Aug 12, 2016TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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