Product Details for ANDA 078794
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE)
5MG;6.25MG
Marketing Status: Prescription
10MG;12.5MG
Marketing Status: Prescription
20MG;12.5MG
Marketing Status: Prescription
20MG;25MG
Marketing Status: Prescription
5MG;6.25MG
Marketing Status: Prescription
Active Ingredient: BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Proprietary Name: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG;6.25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078794
Product Number: 001
Approval Date: Aug 21, 2014
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE)
Proprietary Name: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG;6.25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078794
Product Number: 001
Approval Date: Aug 21, 2014
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information
10MG;12.5MG
Marketing Status: Prescription
Active Ingredient: BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Proprietary Name: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;12.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078794
Product Number: 002
Approval Date: Aug 21, 2014
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE)
Proprietary Name: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;12.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078794
Product Number: 002
Approval Date: Aug 21, 2014
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information
20MG;12.5MG
Marketing Status: Prescription
Active Ingredient: BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Proprietary Name: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG;12.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078794
Product Number: 003
Approval Date: Aug 21, 2014
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE)
Proprietary Name: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG;12.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078794
Product Number: 003
Approval Date: Aug 21, 2014
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information
20MG;25MG
Marketing Status: Prescription
Active Ingredient: BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Proprietary Name: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG;25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078794
Product Number: 004
Approval Date: Aug 21, 2014
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG;25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078794
Product Number: 004
Approval Date: Aug 21, 2014
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information