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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 076557

LORATADINE AND PSEUDOEPHEDRINE SULFATE (LORATADINE; PSEUDOEPHEDRINE SULFATE)
10MG;240MG
Marketing Status: Over-the-counter
Active Ingredient: LORATADINE; PSEUDOEPHEDRINE SULFATE
Proprietary Name: LORATADINE AND PSEUDOEPHEDRINE SULFATE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MG;240MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A076557
Product Number: 001
Approval Date: Sep 22, 2004
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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