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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 078357


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NDA 078357 describes DESLORATADINE, which is a drug marketed by Taro, Reddys, Belcher Pharms, Chartwell Rx, Dash Pharms, Dr Reddys Labs Ltd, Lupin Pharms, Orbion Pharms, Perrigo, and Sun Pharm Inds, and is included in twelve NDAs. It is available from seven 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 078357
Tradename:DESLORATADINE
Applicant:Orbion Pharms
Ingredient:desloratadine
Patents:0
Pharmacology for NDA: 078357
Suppliers and Packaging for NDA: 078357
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESLORATADINE desloratadine TABLET;ORAL 078357 ANDA Bionpharma Inc. 69452-363 69452-363-20 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-363-20)
DESLORATADINE desloratadine TABLET;ORAL 078357 ANDA Bionpharma Inc. 69452-363 69452-363-30 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-363-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Feb 19, 2010TE:ABRLD:No

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