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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078351

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NDA 078351 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 nine 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. One supplier is listed for this compound. Additional details are available on the desloratadine; pseudoephedrine sulfate profile page.
Summary for 078351
Applicant:Mylan Pharms Inc
Therapeutic Class:Respiratory Tract Agents
Pharmacology for NDA: 078351
Suppliers and Packaging for NDA: 078351
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESLORATADINE desloratadine TABLET;ORAL 078351 ANDA Mylan Pharmaceuticals Inc. 0378-4017 N 0378-4017-01
DESLORATADINE desloratadine TABLET;ORAL 078351 ANDA Mylan Pharmaceuticals Inc. 0378-4017 N 0378-4017-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Feb 10, 2012TE:ABRLD:No

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