Details for New Drug Application (NDA): 020786

NDA 020786 describes ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION, which is a drug marketed by Chattem Sanofi and is included in one NDA. It is available from two suppliers. Additional details are available on the ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION profile page.

The generic ingredient in ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION is fexofenadine hydrochloride; pseudoephedrine hydrochloride. There are twenty-three drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.

Summary for 020786

Tradename:	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION
Applicant:	Chattem Sanofi
Ingredient:	fexofenadine hydrochloride; pseudoephedrine hydrochloride
Patents:	0

Pharmacology for NDA: 020786

Mechanism of Action

Adrenergic alpha-Agonists Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 020786

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786	NDA	Chattem, Inc.	41167-4310	41167-4310-2	1 BLISTER PACK in 1 CARTON (41167-4310-2) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786	NDA	Chattem, Inc.	41167-4310	41167-4310-4	2 BLISTER PACK in 1 CARTON (41167-4310-4) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	60MG;120MG
Approval Date:	Jan 24, 2011	TE:		RLD:	Yes

Expired US Patents for NDA 020786

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786-002	Jan 24, 2011	6,113,942*PED
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786-002	Jan 24, 2011	5,578,610*PED
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786-002	Jan 24, 2011	7,138,524*PED
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786-002	Jan 24, 2011	7,135,571*PED
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786-002	Jan 24, 2011	6,187,791*PED
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786-002	Jan 24, 2011	5,855,912*PED
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786-002	Jan 24, 2011	6,037,353*PED

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