Product Details for NDA 021695
ANTARA (MICRONIZED) (FENOFIBRATE)
43MG
Marketing Status: Prescription
130MG
Marketing Status: Prescription
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
87MG
Marketing Status: Discontinued
90MG
Marketing Status: Discontinued
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)
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
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)
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
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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)
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
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)
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
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
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