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    Approved Drug Products containing 78861 listed in the FDA Orange Book. Original Data : FDA Website

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    Aurobindo Pharma Limited

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    01 AUROBINDO PHARMA (1)

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    01 CONCENTRATE;ORAL (1)

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    01 RX (1)

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    01 SERTRALINE HYDROCHLORIDE (1)

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    01 No (1)

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    SERTRALINE HYDROCHLORIDE

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    CONCENTRATE; ORAL
    EQ 20MG BASE/ML
    2008-10-31
    78861
    SERTRALINE HYDROCH...
    RX
    No
    AA
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    Looking for FDA Orange Book APPLICATION 78861

    Looking for FDA Orange Book APPLICATION 78861 1

    19

    Aurobindo Pharma Limited, 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 SERTRALINE HYDROCHLORIDE, with a corresponding application number 78861.

    Regulatory Information RX

    With a dosage strength EQ 20MG BASE/ML

    Dosage Form Route CONCENTRATE; ORAL

    Reference Listed Drug No

    Approved since 2008-10-31

    Therapeutic Equivalence (TE) Code AA

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