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Last Updated: November 21, 2024

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
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:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength30MG
Approval Date:Jan 24, 2011TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jan 24, 2011TE:RLD:Yes

Expired US Patents for NDA 021909

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.