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Last Updated: November 23, 2020

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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 one supplier. There is one patent 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. Twenty-one suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.
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 Chattem, Inc. 41167-4320 41167-4320-5 2 BLISTER PACK in 1 CARTON (41167-4320-5) > 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021704 NDA Chattem, Inc. 41167-4320 41167-4320-7 3 BLISTER PACK in 1 CARTON (41167-4320-7) > 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 021704
Tradename Dosage Ingredient NDA Submissiondate
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION TABLET, EXTENDED RELEASE;ORAL fexofenadine hydrochloride; pseudoephedrine hydrochloride 021704 2007-06-06

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength180MG;240MG
Approval Date:Jan 24, 2011TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Dec 25, 2020Product Flag?YSubstance Flag?Delist Request?

Expired US 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;ORAL 021704-002 Jan 24, 2011   Start Trial   Start Trial
Sanofi Aventis Us ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021704-002 Jan 24, 2011   Start Trial   Start Trial
Sanofi Aventis Us ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION fexofenadine hydrochloride; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 021704-002 Jan 24, 2011   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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