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

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    Apriso

    APIs // Active Pharmaceutical Ingredients

    DEVELOPMENTS

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    DOSSIERs // Finished Dosage Forms

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    01 ABBVIE (4)

    02 SUN PHARM (2)

    03 ACTAVIS LABS FL (1)

    04 ACTAVIS MID ATLANTIC (1)

    05 ALEMBIC (1)

    06 ALKEM LABS LTD (1)

    07 AMNEAL (1)

    08 AMRING PHARMS (1)

    09 AMTA (1)

    10 ANNORA PHARMA (2)

    11 APIL (1)

    12 AUROBINDO PHARMA LTD (1)

    13 ENCUBE (1)

    14 G AND W LABS INC (1)

    15 MEDA PHARMS (1)

    16 MYLAN (3)

    17 MYLAN SPECIALITY LP (2)

    18 PADAGIS ISRAEL (1)

    19 PHARM SOURCING (1)

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    22 SINOTHERAPEUTICS INC (1)

    23 TAKEDA PHARMS USA (3)

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    01 CAPSULE, DELAYED RELEASE;ORAL (2)

    02 CAPSULE, EXTENDED RELEASE;ORAL (11)

    03 ENEMA;RECTAL (5)

    04 SUPPOSITORY;RECTAL (11)

    05 TABLET, DELAYED RELEASE;ORAL (10)

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    01 DISCN (8)

    02 RX (31)

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    01 APRISO (1)

    02 ASACOL (1)

    03 ASACOL HD (1)

    04 CANASA (2)

    05 DELZICOL (1)

    06 LIALDA (1)

    07 MESALAMINE (27)

    08 PENTASA (2)

    09 ROWASA (2)

    10 SFROWASA (1)

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    01 No (29)

    02 Yes (10)

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    ABBVIE

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    MESALAMINE

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    SUPPOSITORY;RECTAL
    500MG
    2001-01-05
    21252
    CANASA
    DISCN
    No
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    EMWA 2024

    Not Confirmed

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    ABBVIE

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    MESALAMINE

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    SUPPOSITORY;RECTAL
    1GM
    2004-11-05
    21252
    CANASA
    RX
    Yes
    AB
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    EMWA 2024

    Not Confirmed

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    ABBVIE

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    MESALAMINE

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    TABLET, DELAYED RELEASE;ORAL
    800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    2008-05-29
    21830
    ASACOL HD
    DISCN
    Yes
    Abbvie Company Banner

    EMWA 2024

    Not Confirmed

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    ABBVIE

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    MESALAMINE

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    CAPSULE, DELAYED RELEASE;ORAL
    400MG
    2013-02-01
    204412
    DELZICOL
    RX
    Yes
    AB
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    EMWA 2024

    Not Confirmed

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    SUN PHARM

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    MESALAMINE

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    TABLET, DELAYED RELEASE;ORAL
    1.2GM
    2019-01-25
    211858
    MESALAMINE
    RX
    No
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    SUN PHARM

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    MESALAMINE

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    CAPSULE, EXTENDED RELEASE;ORAL
    500MG
    2022-05-11
    214585
    MESALAMINE
    RX
    No
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    APIL

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      MESALAMINE

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      TABLET, DELAYED RELEASE;ORAL
      400MG
      1992-01-31
      19651
      ASACOL
      DISCN
      No
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      MEDA PHARMS

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      MESALAMINE

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      SUPPOSITORY;RECTAL
      500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
      1990-12-18
      19919
      ROWASA
      DISCN
      Yes
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      MYLAN SPECIALITY LP

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      MESALAMINE

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      ENEMA;RECTAL
      4GM/60ML
      1987-12-24
      19618
      ROWASA
      RX
      Yes
      AB
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      MYLAN SPECIALITY LP

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      MESALAMINE

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      ENEMA;RECTAL
      4GM/60ML
      2008-06-20
      19618
      SFROWASA
      RX
      Yes
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