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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021621

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CHILDREN'S ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE)
2.5MG
Marketing Status: Over-the-counter
Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S ZYRTEC ALLERGY
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 2.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021621
Product Number: 007
Approval Date: Nov 30, 2020
Applicant Holder Full Name: JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
CHILDREN'S ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE)
10MG
Marketing Status: Over-the-counter
Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S ZYRTEC ALLERGY
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021621
Product Number: 004
Approval Date: Nov 16, 2007
Applicant Holder Full Name: JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
CHILDREN'S ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE)
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S ZYRTEC ALLERGY
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021621
Product Number: 003
Approval Date: Nov 16, 2007
Applicant Holder Full Name: JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV
Marketing Status:  Discontinued
Patent and Exclusivity Information
CHILDREN'S ZYRTEC HIVES RELIEF (CETIRIZINE HYDROCHLORIDE)
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S ZYRTEC HIVES RELIEF
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021621
Product Number: 005
Approval Date: Nov 16, 2007
Applicant Holder Full Name: JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV
Marketing Status:  Discontinued
Patent and Exclusivity Information
CHILDREN'S ZYRTEC HIVES RELIEF (CETIRIZINE HYDROCHLORIDE)
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S ZYRTEC HIVES RELIEF
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021621
Product Number: 006
Approval Date: Nov 16, 2007
Applicant Holder Full Name: JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV
Marketing Status:  Discontinued
Patent and Exclusivity Information
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