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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 078351

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NDA 078351 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 078351

Tradename:	DESLORATADINE
Applicant:	Dash Pharms
Ingredient:	desloratadine
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Feb 10, 2012	TE:		RLD:	No

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