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Generated: January 23, 2019

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Details for New Drug Application (NDA): 022155

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NDA 022155 describes CHILDREN'S ZYRTEC HIVES RELIEF, which is a drug marketed by J And J Consumer Inc and is included in two NDAs. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the CHILDREN'S ZYRTEC HIVES RELIEF profile page.

The generic ingredient in CHILDREN'S ZYRTEC HIVES RELIEF is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and sixty-one suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 022155
Tradename:CHILDREN'S ZYRTEC HIVES RELIEF
Applicant:J And J Consumer Inc
Ingredient:cetirizine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 022155
Suppliers and Packaging for NDA: 022155
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S ZYRTEC ALLERGY cetirizine hydrochloride SYRUP;ORAL 022155 NDA Corporacion Infarmasa 16853-1261 16853-1261-1 1 SYRUP in 1 CARTON (16853-1261-1)
CHILDREN'S ZYRTEC ALLERGY cetirizine hydrochloride SYRUP;ORAL 022155 NDA Corporacion Infarmasa 16853-1261 16853-1261-2 2 SYRUP in 1 PACKAGE, COMBINATION (16853-1261-2)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:Nov 16, 2007TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:Nov 16, 2007TE:RLD:Yes

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