Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020704

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CLARITIN HIVES RELIEF REDITAB (LORATADINE)
10MG
Marketing Status: Over-the-counter
Active Ingredient: LORATADINE
Proprietary Name: CLARITIN HIVES RELIEF REDITAB
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020704
Product Number: 003
Approval Date: Nov 19, 2003
Applicant Holder Full Name: BAYER HEALTHCARE LLC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
CLARITIN REDITABS (LORATADINE)
10MG
Marketing Status: Over-the-counter
Active Ingredient: LORATADINE
Proprietary Name: CLARITIN REDITABS
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020704
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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