Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 208123

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CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY (FEXOFENADINE HYDROCHLORIDE)
30MG/5ML
Marketing Status: Over-the-counter

Active Ingredient: FEXOFENADINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 30MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A208123
Product Number: 001
Approval Date: Nov 9, 2017
Applicant Holder Full Name: TARO PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES (FEXOFENADINE HYDROCHLORIDE)
30MG/5ML
Marketing Status: Over-the-counter

Active Ingredient: FEXOFENADINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 30MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A208123
Product Number: 002
Approval Date: Nov 9, 2017
Applicant Holder Full Name: TARO PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Over-the-counter
Patent and Exclusivity Information