Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 079070

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PERINDOPRIL ERBUMINE (PERINDOPRIL ERBUMINE)
2MG
Marketing Status: Prescription

Active Ingredient: PERINDOPRIL ERBUMINE
Proprietary Name: PERINDOPRIL ERBUMINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A079070
Product Number: 001
Approval Date: Nov 10, 2009
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

PERINDOPRIL ERBUMINE (PERINDOPRIL ERBUMINE)
4MG
Marketing Status: Prescription

Active Ingredient: PERINDOPRIL ERBUMINE
Proprietary Name: PERINDOPRIL ERBUMINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A079070
Product Number: 002
Approval Date: Nov 10, 2009
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

PERINDOPRIL ERBUMINE (PERINDOPRIL ERBUMINE)
8MG
Marketing Status: Prescription

Active Ingredient: PERINDOPRIL ERBUMINE
Proprietary Name: PERINDOPRIL ERBUMINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 8MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A079070
Product Number: 003
Approval Date: Nov 10, 2009
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information