Product Details for ANDA 075868
FENOFIBRATE (MICRONIZED) (FENOFIBRATE)
67MG
Marketing Status: Discontinued
134MG
Marketing Status: Discontinued
200MG
Marketing Status: Discontinued
67MG
Marketing Status: Discontinued
Active Ingredient: FENOFIBRATE
Proprietary Name: FENOFIBRATE (MICRONIZED)
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 67MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A075868
Product Number: 001
Approval Date: Oct 27, 2003
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
FENOFIBRATE (MICRONIZED) (FENOFIBRATE)
Proprietary Name: FENOFIBRATE (MICRONIZED)
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 67MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A075868
Product Number: 001
Approval Date: Oct 27, 2003
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
134MG
Marketing Status: Discontinued
Active Ingredient: FENOFIBRATE
Proprietary Name: FENOFIBRATE (MICRONIZED)
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 134MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A075868
Product Number: 002
Approval Date: Oct 27, 2003
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
FENOFIBRATE (MICRONIZED) (FENOFIBRATE)
Proprietary Name: FENOFIBRATE (MICRONIZED)
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 134MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A075868
Product Number: 002
Approval Date: Oct 27, 2003
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
200MG
Marketing Status: Discontinued
Active Ingredient: FENOFIBRATE
Proprietary Name: FENOFIBRATE (MICRONIZED)
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A075868
Product Number: 003
Approval Date: Oct 27, 2003
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: FENOFIBRATE (MICRONIZED)
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A075868
Product Number: 003
Approval Date: Oct 27, 2003
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information