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Serving leading biopharmaceutical companies globally:

Chubb
Daiichi Sankyo
Mallinckrodt
Fish and Richardson
Teva
Cipla
US Department of Justice
Accenture
UBS
Dow

Generated: October 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078615

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NDA 078615 describes CETIRIZINE HYDROCHLORIDE ALLERGY, which is a drug marketed by Actavis Elizabeth, Apotex Inc, Cipla Ltd, Wockhardt, Bionpharma Inc, Unique Pharm Labs, Sun Pharm Inds Inc, Jubilant Cadista, Perrigo R And D, Dr Reddys Labs Ltd, Sandoz, Contract Pharmacal, Aurobindo Pharma Ltd, Orchid Hlthcare, Taro, Ipca Labs Ltd, Mylan, Amneal Pharms Ny, Unichem, Strides Pharma, Torrent Pharms Llc, and Sun Pharm Inds Ltd, and is included in twenty-five NDAs. It is available from one hundred and twenty-nine 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 sixty-one suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.

Summary for NDA: 078615

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Summary for product number 003

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

Summary for product number 004

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


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Serving leading biopharmaceutical companies globally:

Citi
Medtronic
Johnson and Johnson
Dow
Argus Health
Express Scripts
Cerilliant
QuintilesIMS
Healthtrust
Baxter

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