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Details for New Drug Application (NDA): 021704

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NDA 021704 describes ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from four suppliers. There are three patents protecting this drug. Additional details are available on the ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION profile page.

The generic ingredient in ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION is fexofenadine hydrochloride; pseudoephedrine hydrochloride. There are twenty-three drug master file entries for this compound. Sixteen suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.

Summary for NDA: 021704

Pharmacology for NDA: 021704

Suppliers and Packaging for NDA: 021704

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL 021704 NDA sanofi-aventis U.S. LLC 0088-1095 0088-1095-47 100 TABLET, FILM COATED in 1 BOTTLE (0088-1095-47)
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL 021704 NDA STAT RX USA LLC 16590-852 16590-852-28 28 TABLET, FILM COATED in 1 BOTTLE (16590-852-28)

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength180MG;240MG
Approval Date:Jan 24, 2011TE:RLD:Yes
Patent:6,037,353*PEDPatent Expiration:Sep 14, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:RE39069Patent Expiration:May 29, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:6,613,357Patent Expiration:Dec 25, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:RELIEF OF SYMPTOMS ASSOCIATED WITH RESPIRATORY ALLERGIES, SWELLING OF THE NASAL PASSAGES AND SINUS CONGESTION AND PRESSURE IN ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER

Expired Orange Book Patents for NDA: 021704

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL021704-002Jan 24, 20115,578,610*PED► subscribe
Sanofi Aventis Us
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL021704-002Jan 24, 20117,138,524*PED► subscribe
Sanofi Aventis Us
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION
fexofenadine hydrochloride; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL021704-002Jan 24, 20116,399,632*PED► subscribe
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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 verifification 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.

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