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Last Updated: January 23, 2021

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Details for New Drug Application (NDA): 077829

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NDA 077829 describes CETIRIZINE HYDROCHLORIDE HIVES, which is a drug marketed by Dr Reddys Labs Ltd, Ipca Labs Ltd, Marksans Pharma, Mylan, Orchid Hlthcare, Perrigo R And D, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Unichem, Unique Pharm Labs, Aurobindo Pharma Ltd, Bionpharma Inc, Amneal Pharms Ny, Taro, and Torrent Pharms Llc, and is included in seventeen NDAs. It is available from sixty-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 thirty suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 077829
Tradename:CETIRIZINE HYDROCHLORIDE HIVES
Applicant:Unique Pharm Labs
Ingredient:cetirizine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077829
Medical Subject Heading (MeSH) Categories for 077829
Suppliers and Packaging for NDA: 077829
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 077829 ANDA Rising Pharmaceuticals, Inc. 16571-401 16571-401-10 100 TABLET in 1 BOTTLE (16571-401-10)
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 077829 ANDA Rising Pharmaceuticals, Inc. 16571-402 16571-402-10 100 TABLET in 1 BOTTLE (16571-402-10)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength5MG
Approval Date:Aug 26, 2009TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength10MG
Approval Date:Aug 26, 2009TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength5MG
Approval Date:Aug 26, 2009TE:RLD:No

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