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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
UBS
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Dow
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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078317

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NDA 078317 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-nine suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.

Summary for 078317

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Respiratory Tract Agents
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 0363-1024-04 1 BOTTLE in 1 CARTON (0363-1024-04) > 45 TABLET in 1 BOTTLE

Summary for product number 001

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

Summary for product number 002

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


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Serving leading biopharmaceutical companies globally:

Baxter
Novartis
Moodys
Julphar
UBS
Fuji
Colorcon
Mallinckrodt
Cipla
Harvard Business School

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