Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022155

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CHILDREN'S ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE)
5MG/5ML
Marketing Status: Over-the-counter

Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S ZYRTEC ALLERGY
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 5MG/5ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022155
Product Number: 002
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 HIVES RELIEF (CETIRIZINE HYDROCHLORIDE)
5MG/5ML
Marketing Status: Over-the-counter

Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S ZYRTEC HIVES RELIEF
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 5MG/5ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022155
Product Number: 001
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