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Last Updated: November 4, 2024

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, 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, Taro, Torrent Pharms Llc, Unichem, and Unique, and is included in twenty-eight NDAs. It is available from one hundred and thirty-four 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 fifty-eight 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
Medical Subject Heading (MeSH) Categories for 207235
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 Walgreens 0363-0741 0363-0741-25 1 BOTTLE in 1 BOX (0363-0741-25) / 25 CAPSULE in 1 BOTTLE
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride CAPSULE;ORAL 207235 ANDA Walgreens 0363-0741 0363-0741-40 1 BOTTLE in 1 BOX (0363-0741-40) / 40 CAPSULE 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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