Orange Book product · Generic (ANDA)
FENOFIBRIC ACID
CHOLINE FENOFIBRATE
At a glance
Mar 25, 2013
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 25, 2013
13 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
CHOLINE FENOFIBRATE
Strength
EQ 45MG FENOFIBRIC ACID
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 200913
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CHOLINE FENOFIBRATE
- 2008TRILIPIXBrand (NDA)
NDA 022224 · ABBVIE
- 2024FENOFIBRIC ACIDGeneric (ANDA)
ANDA 207796 · MACLEODS PHARMS LTD
- 2020FENOFIBRIC ACIDGeneric (ANDA)
ANDA 212562 · YICHANG HUMANWELL
- 2020FENOFIBRIC ACIDGeneric (ANDA)
ANDA 213450 · MICRO LABS
- 2019FENOFIBRIC ACIDGeneric (ANDA)
ANDA 212598 · AUROBINDO PHARMA LTD
- 2019FENOFIBRIC ACIDGeneric (ANDA)
ANDA 211626 · RISING
- 2019FENOFIBRIC ACIDGeneric (ANDA)
ANDA 210469 · TWI PHARMS
- 2017FENOFIBRIC ACIDGeneric (ANDA)
ANDA 208705 · ALEMBIC
- 2016FENOFIBRIC ACIDGeneric (ANDA)
ANDA 200264 · IMPAX LABS INC
- 2015FENOFIBRIC ACIDGeneric (ANDA)
ANDA 200920 · ACTAVIS ELIZABETH
- 2013FENOFIBRIC ACIDGeneric (ANDA)
ANDA 200750 · CHARTWELL RX
- 2013FENOFIBRIC ACIDGeneric (ANDA)
ANDA 201573 · PH HEALTH
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.
