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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022429

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CETIRIZINE HYDROCHLORIDE ALLERGY (CETIRIZINE HYDROCHLORIDE)
5MG
Marketing Status: Over-the-counter
Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CETIRIZINE HYDROCHLORIDE ALLERGY
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022429
Product Number: 001
Approval Date: Jul 23, 2009
Applicant Holder Full Name: BIONPHARMA INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
CETIRIZINE HYDROCHLORIDE ALLERGY (CETIRIZINE HYDROCHLORIDE)
10MG
Marketing Status: Over-the-counter
Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CETIRIZINE HYDROCHLORIDE ALLERGY
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022429
Product Number: 004
Approval Date: Jul 23, 2009
Applicant Holder Full Name: BIONPHARMA INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE)
5MG
Marketing Status: Over-the-counter
Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022429
Product Number: 003
Approval Date: Jul 23, 2009
Applicant Holder Full Name: BIONPHARMA INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE)
10MG
Marketing Status: Over-the-counter
Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022429
Product Number: 002
Approval Date: Jul 23, 2009
Applicant Holder Full Name: BIONPHARMA INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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