Product Details for ANDA 091116
CHILDREN'S 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: CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A091116
Product Number: 001
Approval Date: Feb 19, 2015
Applicant Holder Full Name: JUBILANT GENERICS LTD
Marketing Status: Over-the-counter
Patent and Exclusivity Information
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY (CETIRIZINE HYDROCHLORIDE)
Proprietary Name: CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A091116
Product Number: 001
Approval Date: Feb 19, 2015
Applicant Holder Full Name: JUBILANT GENERICS LTD
Marketing Status: Over-the-counter
Patent and Exclusivity Information
10MG
Marketing Status: Over-the-counter
Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A091116
Product Number: 002
Approval Date: Feb 19, 2015
Applicant Holder Full Name: JUBILANT GENERICS LTD
Marketing Status: Over-the-counter
Patent and Exclusivity Information
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE)
Proprietary Name: CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A091116
Product Number: 002
Approval Date: Feb 19, 2015
Applicant Holder Full Name: JUBILANT GENERICS LTD
Marketing Status: Over-the-counter
Patent and Exclusivity Information
5MG
Marketing Status: Over-the-counter
Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A091116
Product Number: 003
Approval Date: Feb 19, 2015
Applicant Holder Full Name: JUBILANT GENERICS LTD
Marketing Status: Over-the-counter
Patent and Exclusivity Information
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE)
Proprietary Name: CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A091116
Product Number: 003
Approval Date: Feb 19, 2015
Applicant Holder Full Name: JUBILANT GENERICS LTD
Marketing Status: Over-the-counter
Patent and Exclusivity Information
10MG
Marketing Status: Over-the-counter
Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A091116
Product Number: 004
Approval Date: Feb 19, 2015
Applicant Holder Full Name: JUBILANT GENERICS LTD
Marketing Status: Over-the-counter
Patent and Exclusivity Information
Proprietary Name: CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A091116
Product Number: 004
Approval Date: Feb 19, 2015
Applicant Holder Full Name: JUBILANT GENERICS LTD
Marketing Status: Over-the-counter
Patent and Exclusivity Information