Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020641

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CLARITIN (LORATADINE)
1MG/ML
Marketing Status: Over-the-counter

Active Ingredient: LORATADINE
Proprietary Name: CLARITIN
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: 1MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020641
Product Number: 002
Approval Date: Nov 27, 2002
Applicant Holder Full Name: BAYER HEALTHCARE LLC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

CLARITIN HIVES RELIEF (LORATADINE)
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: LORATADINE
Proprietary Name: CLARITIN HIVES RELIEF
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020641
Product Number: 003
Approval Date: Nov 19, 2003
Applicant Holder Full Name: BAYER HEALTHCARE LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information