Orange Book product · Brand (NDA)
TRICOR (MICRONIZED)
FENOFIBRATE
At a glance
Feb 09, 1998
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 09, 1998
28 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
FENOFIBRATE
Strength
67MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 019304
Product number
002
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.
- 2013ANTARA (MICRONIZED)Brand (NDA)
NDA 021695 · LUPIN
- 2006LIPOFENBrand (NDA)
NDA 021612 · CIPHER PHARMS INC
- 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.
