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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 078317


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NDA 078317 describes CETIRIZINE HYDROCHLORIDE ALLERGY, which is a drug marketed by Apotex, Aurobindo Pharma Ltd, Bionpharma Inc, Strides Pharma, Sun Pharm Inds Inc, Perrigo R And D, Amneal Pharms Ny, Apotex Inc, Cipla Ltd, Contract Pharmacal, Dr Reddys Labs Ltd, Granules India Ltd, Heritage Pharma, Ipca Labs Ltd, Marksans Pharma, Mylan, Orchid Hlthcare, Pld Acquisitions, Sun Pharm Inds Ltd, Taro, Torrent Pharms Llc, Unichem, Unique Pharm Labs, and Wockhardt, and is included in twenty-seven NDAs. It is available from one hundred and thirteen 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 thirty-three suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 078317
Tradename:CETIRIZINE HYDROCHLORIDE ALLERGY
Applicant:Apotex Inc
Ingredient:cetirizine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 078317
Suppliers and Packaging for NDA: 078317
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 078317 ANDA Walgreen Company 0363-1024 0363-1024-01 1 BOTTLE in 1 CARTON (0363-1024-01) > 150 TABLET in 1 BOTTLE
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 078317 ANDA Walgreen Company 0363-1024 0363-1024-03 1 BOTTLE in 1 CARTON (0363-1024-03) > 300 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength5MG
Approval Date:Dec 27, 2007TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength10MG
Approval Date:Dec 27, 2007TE:RLD:No

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