Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020757

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AVAPRO (IRBESARTAN)
75MG
Marketing Status: Prescription

Active Ingredient: IRBESARTAN
Proprietary Name: AVAPRO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 75MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020757
Product Number: 001
Approval Date: Sep 30, 1997
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

AVAPRO (IRBESARTAN)
150MG
Marketing Status: Prescription

Active Ingredient: IRBESARTAN
Proprietary Name: AVAPRO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020757
Product Number: 002
Approval Date: Sep 30, 1997
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

AVAPRO (IRBESARTAN)
300MG
Marketing Status: Prescription

Active Ingredient: IRBESARTAN
Proprietary Name: AVAPRO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020757
Product Number: 003
Approval Date: Sep 30, 1997
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information