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Details for New Drug Application (NDA): 078351

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NDA 078351 describes DESLORATADINE, which is a drug marketed by Taro, Mylan Pharms Inc, Lupin Pharms, Belcher Pharms, Orchid Hlthcare, Sun Pharm Inds, Perrigo R And D, Sandoz, Dr Reddys Labs Ltd, Reddys, and Taro Pharm Inds, and is included in twelve NDAs. It is available from twelve 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 NDA: 078351

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
TABLET;ORAL 078351 ANDA Mylan Pharmaceuticals Inc. 0378-4017 0378-4017-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4017-01)
TABLET;ORAL 078351 ANDA Mylan Pharmaceuticals Inc. 0378-4017 0378-4017-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4017-05)

Summary for product number 001

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.