Details for New Drug Application (NDA): 078367

NDA 078367 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 078367

Tradename:	DESLORATADINE
Applicant:	Reddys
Ingredient:	desloratadine
Patents:	0

Pharmacology for NDA: 078367

Mechanism of Action

Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 078367

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DESLORATADINE	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	078367	ANDA	Dr. Reddy's Laboratories Limited	55111-360	55111-360-06	6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (55111-360-06)
DESLORATADINE	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	078367	ANDA	Dr. Reddy's Laboratories Limited	55111-360	55111-360-31	5 BLISTER PACK in 1 CARTON (55111-360-31) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	2.5MG
Approval Date:	Jul 12, 2010	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	5MG
Approval Date:	Jul 12, 2010	TE:		RLD:	No

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