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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Farmers Insurance
Harvard Business School
Boehringer Ingelheim

Generated: March 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078427

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NDA 078427 describes CETIRIZINE HYDROCHLORIDE ALLERGY, which is a drug marketed by Apotex Inc, Bionpharma Inc, Strides Pharma, Sun Pharm Inds Inc, Perrigo R And D, Actavis Elizabeth, Amneal Pharms Ny, Aurobindo Pharma Ltd, Cipla Ltd, Contract Pharmacal, Dr Reddys Labs Ltd, Granules India Ltd, Ipca Labs Ltd, Jubilant Cadista, Mylan, Orchid Hlthcare, Pld Acquisitions, Sun Pharm Inds Ltd, Taro, Torrent Pharms Llc, Unichem, Unique Pharm Labs, and Wockhardt, and is included in twenty-six NDAs. It is available from one hundred and twenty-eight 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-seven suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 078427
Ingredient:cetirizine hydrochloride
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 078427
Suppliers and Packaging for NDA: 078427
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 078427 ANDA ASSURED (Greenbrier International, Inc.) 33992-0128 E 33992-0128-4
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 078427 ANDA LIVE BETTER (The Great Atlantic & Pacific Tea Company) 53187-220 N 53187-220-30

Profile for product number 003

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength5MG
Approval Date:Dec 28, 2007TE:RLD:No

Profile for product number 004

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength10MG
Approval Date:Dec 28, 2007TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Daiichi Sankyo
Fish and Richardson

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