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    Approved Drug Products containing 19618 listed in the FDA Orange Book. Original Data : FDA Website

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    Viatris

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    01 MYLAN SPECIALITY LP (2)

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    01 ENEMA;RECTAL (2)

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    02 SFROWASA (1)

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    MESALAMINE

    PDF Supplier PDF
    URL Supplier Web Content
    ENEMA; RECTAL
    4GM/60ML
    1987-12-24
    19618
    ROWASA
    RX
    Yes
    AB
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    MESALAMINE

    PDF Supplier PDF
    URL Supplier Web Content
    ENEMA; RECTAL
    4GM/60ML
    2008-06-20
    19618
    SFROWASA
    RX
    Yes
    AB
    ASK
    US
    PHARMACOMPASS
    Upload
    your Marketing & Sales content

    Looking for FDA Orange Book APPLICATION 19618

    Looking for FDA Orange Book APPLICATION 19618 2

    19

    Viatris, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

    One of their notable products is MESALAMINE, with a corresponding application number 19618.

    Regulatory Information RX

    With a dosage strength 4GM/60ML

    Dosage Form Route ENEMA; RECTAL

    Reference Listed Drug Yes

    Approved since 1987-12-24

    Therapeutic Equivalence (TE) Code AB

    18

    Viatris, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

    One of their notable products is MESALAMINE, with a corresponding application number 19618.

    Regulatory Information RX

    With a dosage strength 4GM/60ML

    Dosage Form Route ENEMA; RECTAL

    Reference Listed Drug Yes

    Approved since 2008-06-20

    Therapeutic Equivalence (TE) Code AB

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