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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021952

CLARITIN (LORATADINE)
10MG
Marketing Status: Over-the-counter
Active Ingredient: LORATADINE
Proprietary Name: CLARITIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021952
Product Number: 001
Approval Date: Jun 16, 2008
Applicant Holder Full Name: BAYER HEALTHCARE LLC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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