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    Approved Drug Products containing 209234 listed in the FDA Orange Book. Original Data : FDA Website

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    Alkem Laboratories

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    01 ALKEM LABS LTD (1)

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    01 TABLET;ORAL (1)

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    01 EZETIMIBE (1)

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    EZETIMIBE

    PDF Supplier PDF
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    TABLET; ORAL
    10MG
    2017-12-21
    209234
    EZETIMIBE
    RX
    No
    AB
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    Looking for FDA Orange Book APPLICATION 209234

    Looking for FDA Orange Book APPLICATION 209234 1

    19

    Alkem Laboratories, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

    One of their notable products is EZETIMIBE, with a corresponding application number 209234.

    Regulatory Information RX

    With a dosage strength 10MG

    Dosage Form Route TABLET; ORAL

    Reference Listed Drug No

    Approved since 2017-12-21

    Therapeutic Equivalence (TE) Code AB

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