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Serving hundreds of leading biopharmaceutical companies globally:

UBS
McKinsey
US Department of Justice
Citi
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Express Scripts
Daiichi Sankyo
Cerilliant
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Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078367

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NDA 078367 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 078367
Tradename:DESLORATADINE
Applicant:Reddys
Ingredient:desloratadine
Patents:0
Therapeutic Class:Respiratory Tract Agents
Pharmacology for NDA: 078367
Suppliers and Packaging for NDA: 078367
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESLORATADINE desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 078367 ANDA Dr. Reddy's Laboratories Limited 55111-360 N 55111-360-06
DESLORATADINE desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 078367 ANDA Dr. Reddy's Laboratories Limited 55111-360 N 55111-360-31

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength2.5MG
Approval Date:Jul 12, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength5MG
Approval Date:Jul 12, 2010TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

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