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    Approved Drug Products containing 21110 listed in the FDA Orange Book. Original Data : FDA Website

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    Pfizer Inc

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    01 Yes (4)

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    SIROLIMUS

    PDF Supplier PDF
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    TABLET; ORAL
    5MG **Federal Regi...
    2004-02-23
    21110
    RAPAMUNE
    DISCN
    Yes
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    SIROLIMUS

    PDF Supplier PDF
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    TABLET; ORAL
    1MG
    2000-08-25
    21110
    RAPAMUNE
    RX
    Yes
    AB
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    SIROLIMUS

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    0.5MG
    2010-01-25
    21110
    RAPAMUNE
    RX
    Yes
    AB
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    SIROLIMUS

    PDF Supplier PDF
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    TABLET; ORAL
    2MG
    2002-08-22
    21110
    RAPAMUNE
    RX
    Yes
    AB
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    Looking for FDA Orange Book APPLICATION 21110

    Looking for FDA Orange Book APPLICATION 21110 4

    19

    Pfizer Inc, 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 SIROLIMUS, with a corresponding application number 21110.

    Regulatory Information DISCN

    With a dosage strength 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 2004-02-23

    18

    Pfizer Inc, 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 SIROLIMUS, with a corresponding application number 21110.

    Regulatory Information RX

    With a dosage strength 1MG

    Dosage Form Route TABLET; ORAL

    Reference Listed Drug Yes

    Approved since 2000-08-25

    Therapeutic Equivalence (TE) Code AB

    17

    Pfizer Inc, 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 SIROLIMUS, with a corresponding application number 21110.

    Regulatory Information RX

    With a dosage strength 0.5MG

    Dosage Form Route TABLET; ORAL

    Reference Listed Drug Yes

    Approved since 2010-01-25

    Therapeutic Equivalence (TE) Code AB

    16

    Pfizer Inc, 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 SIROLIMUS, with a corresponding application number 21110.

    Regulatory Information RX

    With a dosage strength 2MG

    Dosage Form Route TABLET; ORAL

    Reference Listed Drug Yes

    Approved since 2002-08-22

    Therapeutic Equivalence (TE) Code AB

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