Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 216798

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FENOFIBRATE (FENOFIBRATE)
54MG
Marketing Status: Prescription

Active Ingredient: FENOFIBRATE
Proprietary Name: FENOFIBRATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 54MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216798
Product Number: 001
Approval Date: Sep 27, 2022
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

FENOFIBRATE (FENOFIBRATE)
160MG
Marketing Status: Prescription

Active Ingredient: FENOFIBRATE
Proprietary Name: FENOFIBRATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 160MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216798
Product Number: 002
Approval Date: Sep 27, 2022
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information