Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021891

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CHILDREN'S CLARITIN (LORATADINE)
5MG
Marketing Status: Over-the-counter

Active Ingredient: LORATADINE
Proprietary Name: CHILDREN'S CLARITIN
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021891
Product Number: 001
Approval Date: Aug 23, 2006
Applicant Holder Full Name: BAYER HEALTHCARE LLC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

CLARITIN (LORATADINE)
10MG
Marketing Status: Over-the-counter

Active Ingredient: LORATADINE
Proprietary Name: CLARITIN
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021891
Product Number: 002
Approval Date: Nov 21, 2018
Applicant Holder Full Name: BAYER HEALTHCARE LLC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information