Details for New Drug Application (NDA): 078617
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NDA 078617 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, Indoco, 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, Ivax Sub Teva Pharms, and Ppi-dac, and is included in fifty NDAs. It is available from eighteen 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.
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 078617
| Tradename: | CETIRIZINE HYDROCHLORIDE |
| Applicant: | Actavis Mid Atlantic |
| Ingredient: | cetirizine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 078617
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
| Approval Date: | Feb 2, 2010 | TE: | RLD: | No | |||||
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