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Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078876

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NDA 078876 describes CETIRIZINE HYDROCHLORIDE, which is a drug marketed by Actavis Mid Atlantic, Allied Pharma Inc, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Bio Pharm Inc, Breckenridge Pharm, Lannett Co Inc, Perrigo R And D, Ranbaxy Labs Ltd, Taro, Teva Pharms, Wockhardt, Bionpharma Inc, Strides Pharma, Sun Pharm Inds Inc, Actavis Elizabeth, Amneal Pharms Ny, Cipla Ltd, Contract Pharmacal, Dr Reddys Labs Ltd, Granules India Ltd, Ipca Labs Ltd, Jubilant Cadista, Mylan, Orchid Hlthcare, Pld Acquisitions, Sun Pharm Inds Ltd, Torrent Pharms Llc, Unichem, Unique Pharm Labs, and Ivax Sub Teva Pharms, and is included in forty-three NDAs. It is available from thirteen 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. Thirty-four suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.
Summary for 078876
Tradename:CETIRIZINE HYDROCHLORIDE
Applicant:Lannett Co Inc
Ingredient:cetirizine hydrochloride
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078876
Medical Subject Heading (MeSH) Categories for 078876
Suppliers and Packaging for NDA: 078876
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETIRIZINE HYDROCHLORIDE cetirizine hydrochloride SYRUP;ORAL 078876 ANDA Lannett Company, Inc. 54838-571 N 54838-571-40
CETIRIZINE HYDROCHLORIDE cetirizine hydrochloride SYRUP;ORAL 078876 ANDA Lannett Company, Inc. 54838-571 N 54838-571-80

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:May 11, 2012TE:AARLD:No

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Boehringer Ingelheim
Baxter
Dow
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AstraZeneca
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McKesson

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