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Last Updated: July 2, 2022

Details for New Drug Application (NDA): 021621


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NDA 021621 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 one supplier. 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 thirty-three suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 021621
Tradename:CHILDREN'S ZYRTEC HIVES RELIEF
Applicant:J And J Consumer Inc
Ingredient:cetirizine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021621
Medical Subject Heading (MeSH) Categories for 021621
Suppliers and Packaging for NDA: 021621
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S ZYRTEC ALLERGY cetirizine hydrochloride TABLET, CHEWABLE;ORAL 021621 NDA Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division 50580-753 50580-753-24 4 BLISTER PACK in 1 CARTON (50580-753-24) > 6 TABLET, CHEWABLE in 1 BLISTER PACK
CHILDREN'S ZYRTEC HIVES RELIEF cetirizine hydrochloride TABLET, CHEWABLE;ORAL 021621 NDA Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division 50580-753 50580-753-24 4 BLISTER PACK in 1 CARTON (50580-753-24) > 6 TABLET, CHEWABLE in 1 BLISTER PACK

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Nov 16, 2007TE:RLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Nov 16, 2007TE:RLD:Yes

Profile for product number 005

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Nov 16, 2007TE:RLD:Yes

Expired US Patents for NDA 021621

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Serving leading biopharmaceutical companies globally:

McKesson
Merck
Dow
Baxter
Boehringer Ingelheim
Moodys

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