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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Fish and Richardson
Daiichi Sankyo

Generated: March 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076529

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NDA 076529 describes LORATADINE, which is a drug marketed by Marksans Pharma, Taro, Apotex Inc, Perrigo, Ranbaxy Labs Ltd, Silarx, Taro Pharm, Teva, Wockhardt Bio Ag, Actavis Labs Fl Inc, Perrigo Pharma Intl, Pfizer, Mylan, Pld Acquisitions Llc, and Sun Pharm Inds Ltd, and is included in twenty-seven NDAs. It is available from one hundred and twenty-two 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-five suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.
Summary for 076529
Applicant:Ranbaxy Labs Ltd
Formulation / Manufacturing:see details
Pharmacology for NDA: 076529
Medical Subject Heading (MeSH) Categories for 076529
Suppliers and Packaging for NDA: 076529
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LORATADINE loratadine SYRUP;ORAL 076529 ANDA Rebel Distributors Corp 21695-822 E 21695-822-30

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SYRUP;ORALStrength1MG/ML
Approval Date:Aug 20, 2004TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Chinese Patent Office
Johnson and Johnson

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