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Last Updated: November 4, 2024

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, Orbion Pharms, Perrigo R And D, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Unichem, Unique, Aurobindo Pharma Ltd, Bionpharma, Amneal Pharms Ny, Taro, and Torrent Pharms Llc, and is included in seventeen NDAs. It is available from seventy-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 fifty-eight suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 078343
Pharmacology for NDA: 078343
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 Dr. Reddy's Laboratories Inc. 43598-183 43598-183-31 300 TABLET, FILM COATED in 1 BOTTLE (43598-183-31)
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 078343 ANDA Dr. Reddy's Laboratories Inc. 43598-183 43598-183-55 500 TABLET, FILM COATED in 1 BOTTLE (43598-183-55)

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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