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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075822

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NDA 075822 describes LORATADINE, which is a drug marketed by Bionpharma Inc, Marksans Pharma, Taro, Aurobindo Pharma Ltd, Lannett Co Inc, Perrigo, Pharm Assoc, Ranbaxy Labs Ltd, Teva, Wockhardt Bio Ag, Perrigo Pharma Intl, Sun Pharm, Actavis Labs Fl Inc, Pfizer, Apotex Inc, Guardian Drug, Mylan, Pld Acquisitions Llc, Sun Pharm Inds Ltd, Heritage Pharma, and P And L, and is included in thirty-four NDAs. It is available from one hundred and thirty-six suppliers. Additional details are available on the LORATADINE profile page.

The generic ingredient in LORATADINE is loratadine; pseudoephedrine sulfate. There are thirty-nine drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.
Summary for 075822
Tradename:LORATADINE
Applicant:Pfizer
Ingredient:loratadine
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 075822

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength10MG
Approval Date:Feb 10, 2003TE:RLD:No

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