Orange Book product · Brand (NDA)
ANTARA (MICRONIZED)
FENOFIBRATE
At a glance
Oct 18, 2013
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 18, 2013
12 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
FENOFIBRATE
Strength
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 021695
Product number
004
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2006LIPOFENBrand (NDA)
NDA 021612 · CIPHER PHARMS INC
- 1993LIPIDILBrand (NDA)
NDA 019304 · ABBVIE
- 2026FENOFIBRATEGeneric (ANDA)
ANDA 210379 · MACLEODS PHARMS LTD
- 2024FENOFIBRATEGeneric (ANDA)
ANDA 210248 · MACLEODS PHARMS LTD
- 2024FENOFIBRATEGeneric (ANDA)
ANDA 218548 · YICHANG HUMANWELL
- 2024FENOFIBRATE (MICRONIZED)Generic (ANDA)
ANDA 211407 · CHARTWELL
- 2023FENOFIBRATEGeneric (ANDA)
ANDA 217732 · CREEKWOOD PHARMS
- 2022FENOFIBRATEGeneric (ANDA)
ANDA 216798 · AUROBINDO PHARMA
- 2021FENOFIBRATE (MICRONIZED)Generic (ANDA)
ANDA 212232 · AUROBINDO PHARMA LTD
- 2021FENOFIBRATEGeneric (ANDA)
ANDA 208476 · BOSTAL
- 2020FENOFIBRATE (MICRONIZED)Generic (ANDA)
ANDA 213842 · ALEMBIC
- 2020FENOFIBRATEGeneric (ANDA)
ANDA 213864 · MANKIND PHARMA
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
