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    Approved Drug Products containing 208780 listed in the FDA Orange Book. Original Data : FDA Website

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    01 GENENTECH INC (3)

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    01 TABLET;ORAL (3)

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    02 RX (2)

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    PIRFENIDONE

    PDF Supplier PDF
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    TABLET; ORAL
    801MG
    2017-01-11
    208780
    ESBRIET
    RX
    Yes
    AB
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    • EDQM
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    PIRFENIDONE

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    267MG
    2017-01-11
    208780
    ESBRIET
    RX
    Yes
    AB
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    your Marketing & Sales content
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    • FDA
    • EDQM
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    PIRFENIDONE

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    534MG **Federal Re...
    2017-01-11
    208780
    ESBRIET
    DISCN
    Yes
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    Looking for FDA Orange Book APPLICATION 208780

    Looking for FDA Orange Book APPLICATION 208780 3

    19

    Genentech, 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 PIRFENIDONE, with a corresponding application number 208780.

    Regulatory Information RX

    With a dosage strength 801MG

    Dosage Form Route TABLET; ORAL

    Reference Listed Drug Yes

    Approved since 2017-01-11

    Therapeutic Equivalence (TE) Code AB

    18

    Genentech, 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 PIRFENIDONE, with a corresponding application number 208780.

    Regulatory Information RX

    With a dosage strength 267MG

    Dosage Form Route TABLET; ORAL

    Reference Listed Drug Yes

    Approved since 2017-01-11

    Therapeutic Equivalence (TE) Code AB

    17

    Genentech, 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 PIRFENIDONE, with a corresponding application number 208780.

    Regulatory Information DISCN

    With a dosage strength 534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Dosage Form Route TABLET; ORAL

    Reference Listed Drug Yes

    Approved since 2017-01-11

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