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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021695

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ANTARA (MICRONIZED) (FENOFIBRATE)
43MG
Marketing Status: Prescription
Active Ingredient: FENOFIBRATE
Proprietary Name: ANTARA (MICRONIZED)
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 43MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021695
Product Number: 001
Approval Date: Nov 30, 2004
Applicant Holder Full Name: LUPIN INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ANTARA (MICRONIZED) (FENOFIBRATE)
130MG
Marketing Status: Prescription
Active Ingredient: FENOFIBRATE
Proprietary Name: ANTARA (MICRONIZED)
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 130MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021695
Product Number: 003
Approval Date: Nov 30, 2004
Applicant Holder Full Name: LUPIN INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ANTARA (MICRONIZED) (FENOFIBRATE)
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FENOFIBRATE
Proprietary Name: ANTARA (MICRONIZED)
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021695
Product Number: 004
Approval Date: Oct 18, 2013
Applicant Holder Full Name: LUPIN INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ANTARA (MICRONIZED) (FENOFIBRATE)
87MG
Marketing Status: Discontinued
Active Ingredient: FENOFIBRATE
Proprietary Name: ANTARA (MICRONIZED)
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 87MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021695
Product Number: 002
Approval Date: Nov 30, 2004
Applicant Holder Full Name: LUPIN INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ANTARA (MICRONIZED) (FENOFIBRATE)
90MG
Marketing Status: Discontinued
Active Ingredient: FENOFIBRATE
Proprietary Name: ANTARA (MICRONIZED)
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 90MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021695
Product Number: 005
Approval Date: Oct 18, 2013
Applicant Holder Full Name: LUPIN INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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