Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 079213

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IRBESARTAN (IRBESARTAN)
75MG
Marketing Status: Prescription

Active Ingredient: IRBESARTAN
Proprietary Name: IRBESARTAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 75MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A079213
Product Number: 001
Approval Date: Sep 27, 2012
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

IRBESARTAN (IRBESARTAN)
150MG
Marketing Status: Prescription

Active Ingredient: IRBESARTAN
Proprietary Name: IRBESARTAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A079213
Product Number: 002
Approval Date: Sep 27, 2012
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

IRBESARTAN (IRBESARTAN)
300MG
Marketing Status: Prescription

Active Ingredient: IRBESARTAN
Proprietary Name: IRBESARTAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A079213
Product Number: 003
Approval Date: Sep 27, 2012
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information