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Generated: November 15, 2018

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Details for New Drug Application (NDA): 078343

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NDA 078343 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 eighty-three 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 suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 078343
Tradename:CETIRIZINE HYDROCHLORIDE HIVES
Applicant:Dr Reddys Labs Ltd
Ingredient:cetirizine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 078343
Suppliers and Packaging for NDA: 078343
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 078343 ANDA Wal-Mart Stores Inc 49035-010 49035-010-74 1 BLISTER PACK in 1 CARTON (49035-010-74) > 14 TABLET, FILM COATED in 1 BLISTER PACK
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 078343 ANDA Dr.Reddy's Laboratories Limited 55111-351 55111-351-04 1 BOTTLE in 1 CARTON (55111-351-04) > 120 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength5MG
Approval Date:Jan 15, 2008TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength10MG
Approval Date:Jan 15, 2008TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength10MG
Approval Date:Jan 15, 2008TE:RLD:No

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