Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 201546

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

Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 5MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A201546
Product Number: 001
Approval Date: May 20, 2011
Applicant Holder Full Name: TARO PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

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

Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 5MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A201546
Product Number: 002
Approval Date: May 20, 2011
Applicant Holder Full Name: TARO PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Over-the-counter
Patent and Exclusivity Information