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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209090

XYZAL ALLERGY 24HR (LEVOCETIRIZINE DIHYDROCHLORIDE)
2.5MG/5ML
Marketing Status: Over-the-counter
Active Ingredient: LEVOCETIRIZINE DIHYDROCHLORIDE
Proprietary Name: XYZAL ALLERGY 24HR
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 2.5MG/5ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209090
Product Number: 001
Approval Date: Jan 31, 2017
Applicant Holder Full Name: CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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