Details for New Drug Application (NDA): 021909

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NDA 021909 describes CHILDREN'S ALLEGRA HIVES, which is a drug marketed by Chattem Sanofi and is included in three NDAs. It is available from four suppliers. There is one patent protecting this drug. Additional details are available on the CHILDREN'S ALLEGRA HIVES profile page.

The generic ingredient in CHILDREN'S ALLEGRA HIVES is fexofenadine hydrochloride. There are twenty-three drug master file entries for this compound. One hundred and four suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.

Summary for 021909

Tradename:	CHILDREN'S ALLEGRA HIVES
Applicant:	Chattem Sanofi
Ingredient:	fexofenadine hydrochloride
Patents:	0

Pharmacology for NDA: 021909

Mechanism of Action	Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 021909

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHILDREN'S ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021909	NDA	Chattem, Inc.	41167-4232	41167-4232-1	2 BLISTER PACK in 1 CARTON (41167-4232-1) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
CHILDREN'S ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021909	NDA	Chattem, Inc.	41167-4232	41167-4232-6	4 BLISTER PACK in 1 CARTON (41167-4232-6) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	30MG
Approval Date:	Jan 24, 2011	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jan 24, 2011	TE:		RLD:	Yes

Expired US Patents for NDA 021909

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chattem Sanofi	CHILDREN'S ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021909-002	Jan 24, 2011	⤷ Sign Up	⤷ Sign Up
Chattem Sanofi	CHILDREN'S ALLEGRA HIVES	fexofenadine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021909-003	Jan 24, 2011	⤷ Sign Up	⤷ Sign Up
Chattem Sanofi	CHILDREN'S ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021909-002	Jan 24, 2011	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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