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Generated: December 16, 2017

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-one 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 fifty-six suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.

Summary for 078862

Tradename:2
Applicant:1
Ingredient:1
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 16714-271-03 300 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16714-271-03)
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 078862 ANDA Northstar Rx LLC 16714-271 16714-271-02 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16714-271-02)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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