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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019670

CLARITIN-D (LORATADINE; PSEUDOEPHEDRINE SULFATE)
5MG;120MG
Marketing Status: Over-the-counter
Active Ingredient: LORATADINE; PSEUDOEPHEDRINE SULFATE
Proprietary Name: CLARITIN-D
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 5MG;120MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N019670
Product Number: 002
Approval Date: Nov 27, 2002
Applicant Holder Full Name: BAYER HEALTHCARE LLC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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