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Last Updated: April 16, 2024

Details for New Drug Application (NDA): 078072


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NDA 078072 describes CETIRIZINE HYDROCHLORIDE HIVES RELIEF, which is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, Sun Pharm Inds Inc, Amneal Pharms Ny, Taro, and Torrent Pharms Llc, and is included in seven NDAs. It is available from twenty-eight 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 fifty-five suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 078072
Tradename:CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Applicant:Taro
Ingredient:cetirizine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 078072

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength5MG
Approval Date:Jul 22, 2009TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength10MG
Approval Date:Jul 22, 2009TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength5MG
Approval Date:Jul 22, 2009TE:RLD:No

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