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Serving hundreds of leading biopharmaceutical companies globally:

Dow
US Department of Justice
Chinese Patent Office
QuintilesIMS
Cipla
Federal Trade Commission
Express Scripts
US Army
Medtronic

Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078352

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NDA 078352 describes DESLORATADINE, which is a drug marketed by Taro Pharm, Taro Pharm Inds Ltd, Reddys, Belcher Pharms, Dr Reddys Labs Ltd, Lupin Pharms, Mylan Pharms Inc, Orchid Hlthcare, Perrigo R And D, Sandoz, and Sun Pharm Inds, and is included in twelve NDAs. It is available from eleven suppliers. Additional details are available on the DESLORATADINE profile page.

The generic ingredient in DESLORATADINE is desloratadine; pseudoephedrine sulfate. There are sixteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the desloratadine; pseudoephedrine sulfate profile page.
Summary for 078352
Tradename:DESLORATADINE
Applicant:Lupin Pharms
Ingredient:desloratadine
Patents:0
Therapeutic Class:Respiratory Tract Agents
Pharmacology for NDA: 078352
Suppliers and Packaging for NDA: 078352
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESLORATADINE desloratadine TABLET;ORAL 078352 ANDA Lupin Pharmaceuticals, Inc. 68180-153 N 68180-153-01
DESLORATADINE desloratadine TABLET;ORAL 078352 ANDA Lupin Pharmaceuticals, Inc. 68180-153 N 68180-153-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Oct 25, 2010TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Chubb
Merck
Cerilliant
Deloitte
Cantor Fitzgerald
Colorcon
McKesson
Fish and Richardson

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