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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 209274


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NDA 209274 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-one 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-six suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 209274
Tradename:CETIRIZINE HYDROCHLORIDE ALLERGY
Applicant:Granules
Ingredient:cetirizine hydrochloride
Patents:0
Pharmacology for NDA: 209274
Medical Subject Heading (MeSH) Categories for 209274
Suppliers and Packaging for NDA: 209274
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 209274 ANDA Walgreens 0363-0606 0363-0606-03 1 BOTTLE, PLASTIC in 1 BOX (0363-0606-03) / 30 TABLET in 1 BOTTLE, PLASTIC
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 209274 ANDA Walgreens 0363-0606 0363-0606-05 5 BLISTER PACK in 1 CARTON (0363-0606-05) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength10MG
Approval Date:Dec 22, 2017TE:RLD:No

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