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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 078355

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NDA 078355 describes DESLORATADINE, which is a drug marketed by Taro, Reddys, Ajenat 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 078355

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

Pharmacology for NDA: 078355

Mechanism of Action	Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 078355

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DESLORATADINE	desloratadine	TABLET;ORAL	078355	ANDA	A-S Medication Solutions	50090-3975	50090-3975-0	90 TABLET in 1 BOTTLE (50090-3975-0)
DESLORATADINE	desloratadine	TABLET;ORAL	078355	ANDA	A-S Medication Solutions	50090-3975	50090-3975-1	30 TABLET in 1 BOTTLE (50090-3975-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Apr 19, 2012	TE:	AB	RLD:	No

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