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    Approved Drug Products containing 205437 listed in the FDA Orange Book. Original Data : FDA Website

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    Amgen Inc

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    01 AMGEN INC (3)

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    01 TABLET;ORAL (3)

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    01 OTEZLA (3)

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    01 Yes (3)

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    APREMILAST

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    20MG
    2014-03-21
    205437
    OTEZLA
    RX
    Yes
    AB
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    APREMILAST

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    30MG
    2014-03-21
    205437
    OTEZLA
    RX
    Yes
    AB
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    your Marketing & Sales content
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    APREMILAST

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    10MG
    2014-03-21
    205437
    OTEZLA
    RX
    Yes
    AB
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    PHARMACOMPASS
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    Looking for FDA Orange Book APPLICATION 205437

    Looking for FDA Orange Book APPLICATION 205437 3

    19

    Amgen Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is APREMILAST, with a corresponding application number 205437.

    Regulatory Information RX

    With a dosage strength 20MG

    Dosage Form Route TABLET; ORAL

    Reference Listed Drug Yes

    Approved since 2014-03-21

    Therapeutic Equivalence (TE) Code AB

    18

    Amgen Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is APREMILAST, with a corresponding application number 205437.

    Regulatory Information RX

    With a dosage strength 30MG

    Dosage Form Route TABLET; ORAL

    Reference Listed Drug Yes

    Approved since 2014-03-21

    Therapeutic Equivalence (TE) Code AB

    17

    Amgen Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is APREMILAST, with a corresponding application number 205437.

    Regulatory Information RX

    With a dosage strength 10MG

    Dosage Form Route TABLET; ORAL

    Reference Listed Drug Yes

    Approved since 2014-03-21

    Therapeutic Equivalence (TE) Code AB

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