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Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078862

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NDA 078862 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 078862
Tradename:CETIRIZINE HYDROCHLORIDE HIVES
Applicant:Orchid Hlthcare
Ingredient:cetirizine hydrochloride
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 078862
Suppliers and Packaging for NDA: 078862
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 078862 ANDA Northstar Rx LLC 16714-271 N 16714-271-02
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 078862 ANDA Northstar Rx LLC 16714-271 N 16714-271-03

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength5MG
Approval Date:Feb 19, 2009TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength10MG
Approval Date:Feb 19, 2009TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength5MG
Approval Date:Feb 19, 2009TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
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Baxter
Daiichi Sankyo

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