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    Approved Drug Products containing Choline Fenofibrate listed in the FDA Orange Book. Original Data : FDA Website

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    Renejix: CDMO with expertise in small molecule oral dosage, delivery tech, and multi-modality manufacturing.

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    octavius Choline Fenofibrate

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    xyz-pharma-m-2024-10-07

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    IOL Fenofibrate Choline

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    xyz-pharma-m-2024-10-07

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    Choline Fenofibrate

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    01 2ABBVIE

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    03 2ALEMBIC

    04 2AUROBINDO PHARMA LTD

    05 2CHARTWELL RX

    06 2ENDO OPERATIONS

    07 2IMPAX LABS INC

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    01

    ABBVIE

    U.S.A
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    AAPS 2024
    Not Confirmed
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    RLD : Yes

    TE Code : AB

    CHOLINE FENOFIBRATE

    Brand Name : TRILIPIX

    Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

    Dosage Strength : EQ 45MG FENOFIBRIC ACID

    Approval Date : 2008-12-15

    Application Number : 22224

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    ABBVIE

    U.S.A
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    RLD : Yes

    TE Code : AB

    CHOLINE FENOFIBRATE

    Brand Name : TRILIPIX

    Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

    Dosage Strength : EQ 135MG FENOFIBRIC ACID

    Approval Date : 2008-12-15

    Application Number : 22224

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    03

    ACTAVIS ELIZABETH

    Ireland
    AAPS 2024
    Not Confirmed
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    ACTAVIS ELIZABETH

    Ireland
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    RLD : No

    TE Code : AB

    CHOLINE FENOFIBRATE

    Brand Name : FENOFIBRIC ACID

    Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

    Dosage Strength : EQ 45MG FENOFIBRIC ACID

    Approval Date : 2015-10-07

    Application Number : 200920

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    04

    ACTAVIS ELIZABETH

    Ireland
    AAPS 2024
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    ACTAVIS ELIZABETH

    Ireland
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    RLD : No

    TE Code : AB

    CHOLINE FENOFIBRATE

    Brand Name : FENOFIBRIC ACID

    Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

    Dosage Strength : EQ 135MG FENOFIBRIC ACID

    Approval Date : 2015-10-07

    Application Number : 200920

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    05

    CHARTWELL RX

    U.S.A
    AAPS 2024
    Not Confirmed
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    CHARTWELL RX

    U.S.A
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    RLD : No

    TE Code : AB

    CHOLINE FENOFIBRATE

    Brand Name : FENOFIBRIC ACID

    Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

    Dosage Strength : EQ 45MG FENOFIBRIC ACID

    Approval Date : 2013-12-04

    Application Number : 200750

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    06

    CHARTWELL RX

    U.S.A
    AAPS 2024
    Not Confirmed
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    CHARTWELL RX

    U.S.A
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    AAPS 2024
    Not Confirmed
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    RLD : No

    TE Code : AB

    CHOLINE FENOFIBRATE

    Brand Name : FENOFIBRIC ACID

    Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

    Dosage Strength : EQ 135MG FENOFIBRIC ACID

    Approval Date : 2013-12-04

    Application Number : 200750

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    07

    IMPAX LABS INC

    U.S.A
    AAPS 2024
    Not Confirmed
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    IMPAX LABS INC

    U.S.A
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    AAPS 2024
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    RLD : No

    TE Code : AB

    CHOLINE FENOFIBRATE

    Brand Name : FENOFIBRIC ACID

    Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

    Dosage Strength : EQ 45MG FENOFIBRIC ACID

    Approval Date : 2016-09-07

    Application Number : 200264

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    08

    IMPAX LABS INC

    U.S.A
    AAPS 2024
    Not Confirmed
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    IMPAX LABS INC

    U.S.A
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    AAPS 2024
    Not Confirmed
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    • EDQM
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    RLD : No

    TE Code : AB

    CHOLINE FENOFIBRATE

    Brand Name : FENOFIBRIC ACID

    Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

    Dosage Strength : EQ 135MG FENOFIBRIC ACID

    Approval Date : 2016-09-07

    Application Number : 200264

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    09

    NORVIUM BIOSCIENCE

    Country
    AAPS 2024
    Not Confirmed
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    NORVIUM BIOSCIENCE

    Country
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    AAPS 2024
    Not Confirmed
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    RLD : No

    TE Code :

    CHOLINE FENOFIBRATE

    Brand Name : FENOFIBRIC ACID

    Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

    Dosage Strength : EQ 45MG FENOFIBRIC ACID

    Approval Date : 2013-03-25

    Application Number : 200913

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    10

    NORVIUM BIOSCIENCE

    Country
    AAPS 2024
    Not Confirmed
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    NORVIUM BIOSCIENCE

    Country
    arrow
    AAPS 2024
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    RLD : No

    TE Code :

    CHOLINE FENOFIBRATE

    Brand Name : FENOFIBRIC ACID

    Dosage Form : CAPSULE, DELAYED RELEASE;ORAL

    Dosage Strength : EQ 135MG FENOFIBRIC ACID

    Approval Date : 2013-03-25

    Application Number : 200913

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

    blank

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