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    Approved Drug Products containing 22522 listed in the FDA Orange Book. Original Data : FDA Website

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    AstraZeneca

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    01 ASTRAZENECA (2)

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    01 TABLET;ORAL (2)

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    01 RX (2)

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    01 DALIRESP (2)

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    01 Yes (2)

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    ROFLUMILAST

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    250MCG
    2018-01-23
    22522
    DALIRESP
    RX
    Yes
    AB
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    ROFLUMILAST

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    500MCG
    2011-02-28
    22522
    DALIRESP
    RX
    Yes
    AB
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    Looking for FDA Orange Book APPLICATION 22522

    Looking for FDA Orange Book APPLICATION 22522 2

    19

    AstraZeneca, based in United Kingdom, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is ROFLUMILAST, with a corresponding application number 22522.

    Regulatory Information RX

    With a dosage strength 250MCG

    Dosage Form Route TABLET; ORAL

    Reference Listed Drug Yes

    Approved since 2018-01-23

    Therapeutic Equivalence (TE) Code AB

    18

    AstraZeneca, based in United Kingdom, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    One of their notable products is ROFLUMILAST, with a corresponding application number 22522.

    Regulatory Information RX

    With a dosage strength 500MCG

    Dosage Form Route TABLET; ORAL

    Reference Listed Drug Yes

    Approved since 2011-02-28

    Therapeutic Equivalence (TE) Code AB

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