Product Details for ANDA 204097
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY (FEXOFENADINE HYDROCHLORIDE)
30MG
Marketing Status: Over-the-counter
60MG
Marketing Status: Over-the-counter
180MG
Marketing Status: Over-the-counter
30MG
Marketing Status: Over-the-counter
Active Ingredient: FEXOFENADINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A204097
Product Number: 001
Approval Date: Aug 19, 2016
Applicant Holder Full Name: HETERO LABS LTD UNIT V
Marketing Status: Over-the-counter
Patent and Exclusivity Information
FEXOFENADINE HYDROCHLORIDE ALLERGY (FEXOFENADINE HYDROCHLORIDE)
Proprietary Name: CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A204097
Product Number: 001
Approval Date: Aug 19, 2016
Applicant Holder Full Name: HETERO LABS LTD UNIT V
Marketing Status: Over-the-counter
Patent and Exclusivity Information
60MG
Marketing Status: Over-the-counter
Active Ingredient: FEXOFENADINE HYDROCHLORIDE
Proprietary Name: FEXOFENADINE HYDROCHLORIDE ALLERGY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A204097
Product Number: 002
Approval Date: Aug 19, 2016
Applicant Holder Full Name: HETERO LABS LTD UNIT V
Marketing Status: Over-the-counter
Patent and Exclusivity Information
FEXOFENADINE HYDROCHLORIDE ALLERGY (FEXOFENADINE HYDROCHLORIDE)
Proprietary Name: FEXOFENADINE HYDROCHLORIDE ALLERGY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A204097
Product Number: 002
Approval Date: Aug 19, 2016
Applicant Holder Full Name: HETERO LABS LTD UNIT V
Marketing Status: Over-the-counter
Patent and Exclusivity Information
180MG
Marketing Status: Over-the-counter
Active Ingredient: FEXOFENADINE HYDROCHLORIDE
Proprietary Name: FEXOFENADINE HYDROCHLORIDE ALLERGY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 180MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A204097
Product Number: 003
Approval Date: Aug 19, 2016
Applicant Holder Full Name: HETERO LABS LTD UNIT V
Marketing Status: Over-the-counter
Patent and Exclusivity Information
Proprietary Name: FEXOFENADINE HYDROCHLORIDE ALLERGY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 180MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A204097
Product Number: 003
Approval Date: Aug 19, 2016
Applicant Holder Full Name: HETERO LABS LTD UNIT V
Marketing Status: Over-the-counter
Patent and Exclusivity Information