Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 202252

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FENOFIBRATE (MICRONIZED) (FENOFIBRATE)
43MG
Marketing Status: Prescription

Active Ingredient: FENOFIBRATE
Proprietary Name: FENOFIBRATE (MICRONIZED)
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 43MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202252
Product Number: 001
Approval Date: Jul 26, 2013
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

FENOFIBRATE (MICRONIZED) (FENOFIBRATE)
130MG
Marketing Status: Prescription

Active Ingredient: FENOFIBRATE
Proprietary Name: FENOFIBRATE (MICRONIZED)
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 130MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202252
Product Number: 002
Approval Date: Jul 26, 2013
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information