Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 209107

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CETIRIZINE HYDROCHLORIDE ALLERGY (CETIRIZINE HYDROCHLORIDE)
10MG
Marketing Status: Over-the-counter

Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CETIRIZINE HYDROCHLORIDE ALLERGY
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A209107
Product Number: 001
Approval Date: Jul 20, 2018
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE)
10MG
Marketing Status: Over-the-counter

Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A209107
Product Number: 002
Approval Date: Jul 20, 2018
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Over-the-counter
Patent and Exclusivity Information