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Last Updated: July 13, 2020

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Details for New Drug Application (NDA): 079191


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NDA 079191 describes CETIRIZINE HYDROCHLORIDE HIVES RELIEF, which is a drug marketed by Aurobindo Pharma Ltd, Bionpharma Inc, Sun Pharm Inds Inc, Amneal Pharms Ny, Taro, and Torrent Pharms Llc, and is included in seven NDAs. It is available from thirty-seven suppliers. Additional details are available on the CETIRIZINE HYDROCHLORIDE HIVES RELIEF profile page.

The generic ingredient in CETIRIZINE HYDROCHLORIDE HIVES RELIEF is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and thirty-three suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 079191
Tradename:CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Applicant:Torrent Pharms Llc
Ingredient:cetirizine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 079191

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength5MG
Approval Date:Apr 15, 2010TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength10MG
Approval Date:Apr 15, 2010TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength5MG
Approval Date:Apr 15, 2010TE:RLD:No

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