Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078212

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BENAZEPRIL HYDROCHLORIDE (BENAZEPRIL HYDROCHLORIDE)
10MG
Marketing Status: Prescription

Active Ingredient: BENAZEPRIL HYDROCHLORIDE
Proprietary Name: BENAZEPRIL HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078212
Product Number: 001
Approval Date: May 22, 2008
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

BENAZEPRIL HYDROCHLORIDE (BENAZEPRIL HYDROCHLORIDE)
20MG
Marketing Status: Prescription

Active Ingredient: BENAZEPRIL HYDROCHLORIDE
Proprietary Name: BENAZEPRIL HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078212
Product Number: 002
Approval Date: May 22, 2008
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

BENAZEPRIL HYDROCHLORIDE (BENAZEPRIL HYDROCHLORIDE)
40MG
Marketing Status: Prescription

Active Ingredient: BENAZEPRIL HYDROCHLORIDE
Proprietary Name: BENAZEPRIL HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A078212
Product Number: 003
Approval Date: May 22, 2008
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information