Product Details for ANDA 078336
CETIRIZINE HYDROCHLORIDE ALLERGY (CETIRIZINE HYDROCHLORIDE)
5MG
Marketing Status: Over-the-counter
10MG
Marketing Status: Over-the-counter
5MG
Marketing Status: Over-the-counter
10MG
Marketing Status: Over-the-counter
5MG
Marketing Status: Over-the-counter
Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CETIRIZINE HYDROCHLORIDE ALLERGY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078336
Product Number: 001
Approval Date: Dec 27, 2007
Applicant Holder Full Name: PERRIGO R AND D CO
Marketing Status: Over-the-counter
Patent and Exclusivity Information
CETIRIZINE HYDROCHLORIDE ALLERGY (CETIRIZINE HYDROCHLORIDE)
Proprietary Name: CETIRIZINE HYDROCHLORIDE ALLERGY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078336
Product Number: 001
Approval Date: Dec 27, 2007
Applicant Holder Full Name: PERRIGO R AND D CO
Marketing Status: Over-the-counter
Patent and Exclusivity Information
10MG
Marketing Status: Over-the-counter
Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CETIRIZINE HYDROCHLORIDE ALLERGY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078336
Product Number: 002
Approval Date: Dec 27, 2007
Applicant Holder Full Name: PERRIGO R AND D CO
Marketing Status: Over-the-counter
Patent and Exclusivity Information
CETIRIZINE HYDROCHLORIDE HIVES (CETIRIZINE HYDROCHLORIDE)
Proprietary Name: CETIRIZINE HYDROCHLORIDE ALLERGY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078336
Product Number: 002
Approval Date: Dec 27, 2007
Applicant Holder Full Name: PERRIGO R AND D CO
Marketing Status: Over-the-counter
Patent and Exclusivity Information
5MG
Marketing Status: Over-the-counter
Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CETIRIZINE HYDROCHLORIDE HIVES
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078336
Product Number: 003
Approval Date: Dec 27, 2007
Applicant Holder Full Name: PERRIGO R AND D CO
Marketing Status: Over-the-counter
Patent and Exclusivity Information
CETIRIZINE HYDROCHLORIDE HIVES (CETIRIZINE HYDROCHLORIDE)
Proprietary Name: CETIRIZINE HYDROCHLORIDE HIVES
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078336
Product Number: 003
Approval Date: Dec 27, 2007
Applicant Holder Full Name: PERRIGO R AND D CO
Marketing Status: Over-the-counter
Patent and Exclusivity Information
10MG
Marketing Status: Over-the-counter
Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CETIRIZINE HYDROCHLORIDE HIVES
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078336
Product Number: 004
Approval Date: Dec 27, 2007
Applicant Holder Full Name: PERRIGO R AND D CO
Marketing Status: Over-the-counter
Patent and Exclusivity Information
Proprietary Name: CETIRIZINE HYDROCHLORIDE HIVES
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078336
Product Number: 004
Approval Date: Dec 27, 2007
Applicant Holder Full Name: PERRIGO R AND D CO
Marketing Status: Over-the-counter
Patent and Exclusivity Information