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Last Updated: July 6, 2020

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Details for New Drug Application (NDA): 209089

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NDA 209089 describes XYZAL ALLERGY 24HR, which is a drug marketed by Sanofi Aventis Us and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the XYZAL ALLERGY 24HR profile page.

The generic ingredient in XYZAL ALLERGY 24HR is levocetirizine dihydrochloride. There are thirteen drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.
Summary for 209089
Applicant:Sanofi Aventis Us
Ingredient:levocetirizine dihydrochloride
Suppliers and Packaging for NDA: 209089
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XYZAL ALLERGY 24HR levocetirizine dihydrochloride TABLET;ORAL 209089 NDA Chattem, Inc. 41167-3510 41167-3510-0 1 BLISTER PACK in 1 CARTON (41167-3510-0) > 10 TABLET in 1 BLISTER PACK
XYZAL ALLERGY 24HR levocetirizine dihydrochloride TABLET;ORAL 209089 NDA Chattem, Inc. 41167-3510 41167-3510-1 1 BOTTLE in 1 CARTON (41167-3510-1) > 35 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength5MG
Approval Date:Jan 31, 2017TE:RLD:Yes

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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson

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