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Generated: November 17, 2017

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Details for New Drug Application (NDA): 078412

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NDA 078412 describes CETIRIZINE HYDROCHLORIDE, which is a drug marketed by Taro, Apotex Inc, Actavis Mid Atlantic, Aurobindo Pharma Ltd, Wockhardt, Amneal Pharms, Bio Pharm Inc, Ranbaxy Labs Ltd, Silarx, Teva Pharms, Breckenridge Pharm, Allied Pharma Inc, Vintage, Perrigo R And D, Actavis Elizabeth, Cipla Ltd, Bionpharma Inc, Unique Pharm Labs, Sun Pharm Inds Inc, Jubilant Cadista, Dr Reddys Labs Ltd, Sandoz, Contract Pharmacal, Orchid Hlthcare, Ipca Labs Ltd, Mylan, Amneal Pharms Ny, Unichem, Strides Pharma, Torrent Pharms Llc, Sun Pharm Inds Ltd, and Ivax Sub Teva Pharms, and is included in forty-two NDAs. It is available from fifteen 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-two suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.

Summary for 078412

Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:Jun 18, 2008TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Express Scripts
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Chinese Patent Office
Daiichi Sankyo
Argus Health

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