Product Details for ANDA 077631
CETIRIZINE HYDROCHLORIDE ALLERGY (CETIRIZINE HYDROCHLORIDE)
5MG
Marketing Status: Discontinued
10MG
Marketing Status: Discontinued
5MG
Marketing Status: Discontinued
10MG
Marketing Status: Discontinued
5MG
Marketing Status: Discontinued
Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CETIRIZINE HYDROCHLORIDE ALLERGY
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A077631
Product Number: 004
Approval Date: Jan 11, 2008
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
CETIRIZINE HYDROCHLORIDE ALLERGY (CETIRIZINE HYDROCHLORIDE)
Proprietary Name: CETIRIZINE HYDROCHLORIDE ALLERGY
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A077631
Product Number: 004
Approval Date: Jan 11, 2008
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
10MG
Marketing Status: Discontinued
Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: CETIRIZINE HYDROCHLORIDE ALLERGY
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A077631
Product Number: 003
Approval Date: Jan 11, 2008
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE)
Proprietary Name: CETIRIZINE HYDROCHLORIDE ALLERGY
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A077631
Product Number: 003
Approval Date: Jan 11, 2008
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
5MG
Marketing Status: Discontinued
Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: 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: A077631
Product Number: 001
Approval Date: Jan 11, 2008
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
CETIRIZINE HYDROCHLORIDE HIVES RELIEF (CETIRIZINE HYDROCHLORIDE)
Proprietary Name: 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: A077631
Product Number: 001
Approval Date: Jan 11, 2008
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
10MG
Marketing Status: Discontinued
Active Ingredient: CETIRIZINE HYDROCHLORIDE
Proprietary Name: 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: A077631
Product Number: 002
Approval Date: Jan 11, 2008
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: 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: A077631
Product Number: 002
Approval Date: Jan 11, 2008
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information