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    Approved Drug Products containing 216184 listed in the FDA Orange Book. Original Data : FDA Website

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    Zydus Lifesciences

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    01 ZYDUS (1)

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    01 SUPPOSITORY;RECTAL (1)

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    01 RX (1)

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    01 INDOMETHACIN (1)

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    01 No (1)

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    INDOMETHACIN

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    SUPPOSITORY; RECTA...
    50MG
    2023-08-02
    216184
    INDOMETHACIN
    RX
    No
    AB
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    Looking for FDA Orange Book APPLICATION 216184

    Looking for FDA Orange Book APPLICATION 216184 1

    19

    Zydus Lifesciences, 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 INDOMETHACIN, with a corresponding application number 216184.

    Regulatory Information RX

    With a dosage strength 50MG

    Dosage Form Route SUPPOSITORY; RECTAL

    Reference Listed Drug No

    Approved since 2023-08-02

    Therapeutic Equivalence (TE) Code AB

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