BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Farmers Insurance
Argus Health

Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078364

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NDA 078364 describes DESLORATADINE, which is a drug marketed by Taro Pharm, Taro Pharm Inds, 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 078364

Therapeutic Class:Respiratory Tract Agents

Pharmacology for NDA: 078364

Suppliers and Packaging for NDA: 078364

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESLORATADINE desloratadine TABLET;ORAL 078364 ANDA Sandoz Inc 0781-5226 0781-5226-01 100 TABLET in 1 BOTTLE (0781-5226-01)
DESLORATADINE desloratadine TABLET;ORAL 078364 ANDA Sandoz Inc 0781-5226 0781-5226-64 3 BLISTER PACK in 1 CARTON (0781-5226-64) > 10 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Dec 3, 2010TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Fish and Richardson
US Department of Justice
Federal Trade Commission

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