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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Daiichi Sankyo
US Department of Justice
Harvard Business School

Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076557

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NDA 076557 describes LORATADINE AND PSEUDOEPHEDRINE SULFATE, which is a drug marketed by Actavis Labs Fl Inc, Perrigo Pharma Intl, and Sun Pharm Inds Ltd, and is included in five NDAs. It is available from forty-four suppliers. Additional details are available on the LORATADINE AND PSEUDOEPHEDRINE SULFATE profile page.

The generic ingredient in LORATADINE AND PSEUDOEPHEDRINE SULFATE 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 076557
Applicant:Sun Pharm Inds Ltd
Ingredient:loratadine; pseudoephedrine sulfate
Formulation / Manufacturing:see details
Pharmacology for NDA: 076557
Mechanism of ActionAdrenergic alpha-Agonists
Suppliers and Packaging for NDA: 076557
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LORATADINE AND PSEUDOEPHEDRINE SULFATE loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 076557 ANDA Walgreen Company 0363-0725 N 0363-0725-56
LORATADINE AND PSEUDOEPHEDRINE SULFATE loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 076557 ANDA Walgreen Company 0363-0725 N 0363-0725-69

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG;240MG
Approval Date:Sep 22, 2004TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
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