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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 208709

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FENOFIBRATE (FENOFIBRATE)
48MG
Marketing Status: Prescription
Active Ingredient: FENOFIBRATE
Proprietary Name: FENOFIBRATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 48MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208709
Product Number: 001
Approval Date: Dec 15, 2016
Applicant Holder Full Name: CIPLA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
FENOFIBRATE (FENOFIBRATE)
145MG
Marketing Status: Prescription
Active Ingredient: FENOFIBRATE
Proprietary Name: FENOFIBRATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 145MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208709
Product Number: 002
Approval Date: Dec 15, 2016
Applicant Holder Full Name: CIPLA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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