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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 078398


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NDA 078398 describes CETIRIZINE HYDROCHLORIDE, which is a drug marketed by Actavis Mid Atlantic, Amneal Pharms, Apozeal Pharms, Aurobindo Pharma Ltd, Bajaj, Bionpharma, Chartwell Molecular, Lannett Co Inc, Padagis Us, Pharm Assoc, Ranbaxy Labs Ltd, Taro, Teva Pharms, Wockhardt, Apotex, Catalent, Strides Pharma, Sun Pharm Inds Inc, Perrigo R And D, Amneal Pharms Ny, Apotex Inc, Cipla Ltd, Contract Pharmacal, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Granules, Heritage Pharma, Ipca Labs Ltd, Marksans Pharma, Mylan, Orbion Pharms, Pld Acquisitions, Sun Pharm Inds Ltd, Torrent Pharms Llc, Unichem, Unique, and Ivax Sub Teva Pharms, and is included in forty-eight NDAs. It is available from sixteen suppliers. Additional details are available on the CETIRIZINE HYDROCHLORIDE profile page.

The generic ingredient in CETIRIZINE HYDROCHLORIDE is cetirizine hydrochloride; pseudoephedrine hydrochloride. There are thirty-nine drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.
Summary for 078398
Tradename:CETIRIZINE HYDROCHLORIDE
Applicant:Padagis Us
Ingredient:cetirizine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078398
Medical Subject Heading (MeSH) Categories for 078398
Suppliers and Packaging for NDA: 078398
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETIRIZINE HYDROCHLORIDE cetirizine hydrochloride SYRUP;ORAL 078398 ANDA Padagis Israel Pharmaceuticals Ltd 45802-626 45802-626-26 1 BOTTLE in 1 CARTON (45802-626-26) / 120 mL in 1 BOTTLE
CETIRIZINE HYDROCHLORIDE cetirizine hydrochloride SYRUP;ORAL 078398 ANDA A-S Medication Solutions 50090-4288 50090-4288-0 1 BOTTLE in 1 CARTON (50090-4288-0) / 120 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:Jun 17, 2008TE:AARLD:No

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