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Generated: November 13, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077499

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NDA 077499 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-four 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-one suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 077499
Tradename:CETIRIZINE HYDROCHLORIDE HIVES
Applicant:Sun Pharm Inds Inc
Ingredient:cetirizine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 077499
Suppliers and Packaging for NDA: 077499
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 077499 ANDA Caraco Pharmaceutical Laboratories, Ltd. 57664-540 57664-540-26 500 TABLET, FILM COATED in 1 BOTTLE (57664-540-26)
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 077499 ANDA Caraco Pharmaceutical Laboratories, Ltd. 57664-540 57664-540-27 1000 TABLET, FILM COATED in 1 BOTTLE (57664-540-27)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength5MG
Approval Date:Dec 27, 2007TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength10MG
Approval Date:Dec 27, 2007TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength5MG
Approval Date:Dec 27, 2007TE:RLD:No

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