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Last Updated: May 13, 2021

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Details for New Drug Application (NDA): 075565

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NDA 075565 describes LORATADINE, which is a drug marketed by Bionpharma Inc, Marksans Pharma, Strides 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, Glaxosmithkline, Rubicon, Tenshi, Apotex Inc, Granules, Guardian Drug, Mylan, Pld Acquisitions Llc, Sun Pharm Inds Ltd, Unique Pharm, Heritage Pharma, and P And L, and is included in forty NDAs. It is available from one hundred and eleven 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. Thirty-seven suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.
Summary for 075565
Applicant:Pharm Assoc
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 075565

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SYRUP;ORALStrength1MG/ML
Approval Date:Oct 5, 2004TE:RLD:No

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Serving leading biopharmaceutical companies globally:

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