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Serving leading biopharmaceutical companies globally:

US Army
Queensland Health
Boehringer Ingelheim
Johnson and Johnson
Covington
Harvard Business School
Farmers Insurance
Chubb
Cerilliant
QuintilesIMS

Generated: January 18, 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, Ipca Labs Ltd, Jubilant Cadista, Mylan, Orchid Hlthcare, Sandoz, Sun Pharm Inds Ltd, Taro, Torrent Pharms Llc, Unichem, Unique Pharm Labs, and Wockhardt, and is included in twenty-five NDAs. It is available from one hundred and twenty-six 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 078427
Tradename:CETIRIZINE HYDROCHLORIDE ALLERGY
Applicant:Wockhardt
Ingredient:cetirizine hydrochloride
Patents:0
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 33992-0128-4 1 BLISTER PACK in 1 CARTON (33992-0128-4) > 14 TABLET in 1 BLISTER PACK
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 078427 ANDA LIVE BETTER (The Great Atlantic & Pacific Tea Company) 53187-220 53187-220-30 2 BLISTER PACK in 1 CARTON (53187-220-30) > 15 TABLET in 1 BLISTER PACK

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 leading biopharmaceutical companies globally:

Argus Health
AstraZeneca
Moodys
Medtronic
Accenture
Baxter
US Department of Justice
Boehringer Ingelheim
Fuji

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