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Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076677

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NDA 076677 describes CETIRIZINE HYDROCHLORIDE HIVES, which is a drug marketed by Dr Reddys Labs Ltd, Ipca Labs Ltd, Jubilant Cadista, Mylan, Orchid Hlthcare, Perrigo R And D, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Unichem, Unique Pharm Labs, Bionpharma Inc, Amneal Pharms Ny, Aurobindo Pharma Ltd, Taro, and Torrent Pharms Llc, and is included in sixteen NDAs. It is available from eighty-five suppliers. Additional details are available on the CETIRIZINE HYDROCHLORIDE HIVES profile page.

The generic ingredient in CETIRIZINE HYDROCHLORIDE HIVES 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 076677
Tradename:CETIRIZINE HYDROCHLORIDE HIVES
Applicant:Mylan
Ingredient:cetirizine hydrochloride
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 076677
Suppliers and Packaging for NDA: 076677
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 076677 ANDA Mylan Pharmaceuticals Inc. 0378-3635 N 0378-3635-01
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 076677 ANDA Mylan Pharmaceuticals Inc. 0378-3637 N 0378-3637-01

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

Profile for product number 003

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

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Chinese Patent Office
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