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Generated: November 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077946

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NDA 077946 describes CETIRIZINE HYDROCHLORIDE ALLERGY, which is a drug marketed by Apotex Inc, Aurobindo Pharma Ltd, Bionpharma Inc, Strides Pharma, Sun Pharm Inds Inc, Perrigo R And D, Actavis Elizabeth, Amneal Pharms Ny, Cipla Ltd, Contract Pharmacal, Dr Reddys Labs Ltd, Granules India Ltd, 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 thirty 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 suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 077946
Tradename:CETIRIZINE HYDROCHLORIDE ALLERGY
Applicant:Pld Acquisitions
Ingredient:cetirizine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077946
Medical Subject Heading (MeSH) Categories for 077946
Suppliers and Packaging for NDA: 077946
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 077946 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7522 0615-7522-39 30 TABLET in 1 BLISTER PACK (0615-7522-39)
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 077946 ANDA Sandoz Inc 0781-1683 0781-1683-01 100 TABLET in 1 BOTTLE (0781-1683-01)

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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