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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 077498


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NDA 077498 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 077498
Pharmacology for NDA: 077498
Medical Subject Heading (MeSH) Categories for 077498
Suppliers and Packaging for NDA: 077498
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 077498 ANDA Marlex Pharmaceuticals, Inc 10135-762 10135-762-01 100 TABLET in 1 BOTTLE (10135-762-01)
CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET;ORAL 077498 ANDA Marlex Pharmaceuticals, Inc 10135-762 10135-762-03 300 TABLET in 1 BOTTLE (10135-762-03)

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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