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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022118

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FENOGLIDE (FENOFIBRATE)
40MG
Marketing Status: Prescription
Active Ingredient: FENOFIBRATE
Proprietary Name: FENOGLIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022118
Product Number: 001
Approval Date: Aug 10, 2007
Applicant Holder Full Name: SALIX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
FENOGLIDE (FENOFIBRATE)
120MG
Marketing Status: Prescription
Active Ingredient: FENOFIBRATE
Proprietary Name: FENOGLIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 120MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022118
Product Number: 002
Approval Date: Aug 10, 2007
Applicant Holder Full Name: SALIX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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