Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021612

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LIPOFEN (FENOFIBRATE)
50MG
Marketing Status: Prescription

Active Ingredient: FENOFIBRATE
Proprietary Name: LIPOFEN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021612
Product Number: 001
Approval Date: Jan 11, 2006
Applicant Holder Full Name: CIPHER PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

LIPOFEN (FENOFIBRATE)
150MG
Marketing Status: Prescription

Active Ingredient: FENOFIBRATE
Proprietary Name: LIPOFEN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 150MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021612
Product Number: 003
Approval Date: Jan 11, 2006
Applicant Holder Full Name: CIPHER PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

LIPOFEN (FENOFIBRATE)
100MG
Marketing Status: Discontinued

Active Ingredient: FENOFIBRATE
Proprietary Name: LIPOFEN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021612
Product Number: 002
Approval Date: Jan 11, 2006
Applicant Holder Full Name: CIPHER PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information