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Details for New Drug Application (NDA): 078361

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NDA 078361 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: 078361

Tradename:
DESLORATADINE
Applicant:
Perrigo R And D
Ingredient:
desloratadine
Patents:0
Therapeutic Class:Respiratory Tract Agents

Pharmacology for NDA: 078361

Suppliers and Packaging for NDA: 078361

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESLORATADINE
desloratadine
TABLET;ORAL 078361 ANDA Paddock Laboratories, LLC 0574-9838 0574-9838-01 100 TABLET, FILM COATED in 1 BOTTLE (0574-9838-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Dec 22, 2011TE:ABRLD:No


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