Details for New Drug Application (NDA): 076050

NDA 076050 describes LORATADINE AND PSEUDOEPHEDRINE SULFATE, which is a drug marketed by Bionpharma, Heritage Pharma, P And L, Perrigo Pharma Intl, and Sun Pharm Inds Ltd, and is included in six NDAs. It is available from thirty-two suppliers. Additional details are available on the LORATADINE AND PSEUDOEPHEDRINE SULFATE profile page.

The generic ingredient in LORATADINE AND PSEUDOEPHEDRINE SULFATE is loratadine; pseudoephedrine sulfate. There are thirty-nine drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.

Summary for 076050

Tradename:	LORATADINE AND PSEUDOEPHEDRINE SULFATE
Applicant:	Perrigo Pharma Intl
Ingredient:	loratadine; pseudoephedrine sulfate
Patents:	0

Pharmacology for NDA: 076050

Mechanism of Action

Adrenergic alpha-Agonists

Suppliers and Packaging for NDA: 076050

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LORATADINE AND PSEUDOEPHEDRINE SULFATE	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	076050	ANDA	L. Perrigo Company	0113-2007	0113-2007-60	20 BLISTER PACK in 1 CARTON (0113-2007-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
LORATADINE AND PSEUDOEPHEDRINE SULFATE	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	076050	ANDA	L. Perrigo Company	0113-7777	0113-7777-60	20 BLISTER PACK in 1 CARTON (0113-7777-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	5MG;120MG
Approval Date:	Jan 30, 2003	TE:		RLD:	No

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