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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 208705

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FENOFIBRIC ACID (CHOLINE FENOFIBRATE)
EQ 45MG FENOFIBRIC ACID
Marketing Status: Prescription
Active Ingredient: CHOLINE FENOFIBRATE
Proprietary Name: FENOFIBRIC ACID
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: EQ 45MG FENOFIBRIC ACID
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208705
Product Number: 001
Approval Date: May 12, 2017
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
FENOFIBRIC ACID (CHOLINE FENOFIBRATE)
EQ 135MG FENOFIBRIC ACID
Marketing Status: Prescription
Active Ingredient: CHOLINE FENOFIBRATE
Proprietary Name: FENOFIBRIC ACID
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: EQ 135MG FENOFIBRIC ACID
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208705
Product Number: 002
Approval Date: May 12, 2017
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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