Last Updated: June 17, 2026

Details for New Drug Application (NDA): 078351

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NDA 078351 describes DESLORATADINE, which is a drug marketed by Taro, Reddys, Ajenat Pharms, Chartwell Rx, Dr Reddys Labs Ltd, Lupin Pharms, Natco Pharma Usa, Orbion Pharms, Perrigo, and Sun Pharm Inds, and is included in twelve NDAs. It is available from eight 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:	Natco Pharma Usa
Ingredient:	desloratadine
Patents:	0

Pharmacology for NDA: 078351

Mechanism of Action	Histamine H1 Receptor Antagonists

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	Natco Pharma USA LLC	69339-194	69339-194-01	100 TABLET, FILM COATED in 1 BOTTLE (69339-194-01)
DESLORATADINE	desloratadine	TABLET;ORAL	078351	ANDA	Natco Pharma USA LLC	69339-194	69339-194-05	500 TABLET, FILM COATED in 1 BOTTLE (69339-194-05)

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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