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    Approved Drug Products containing 203438 listed in the FDA Orange Book. Original Data : FDA Website

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    Ajanta Pharma Limited

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    01 AJANTA PHARMA LTD (1)

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    01 GRANULE;ORAL (1)

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    01 MONTELUKAST SODIUM (1)

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    01 No (1)

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    MONTELUKAST SODIUM

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    GRANULE; ORAL
    EQ 4MG BASE/PACKET
    2015-07-31
    203438
    MONTELUKAST SODIUM
    RX
    No
    AB
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    Looking for FDA Orange Book APPLICATION 203438

    Looking for FDA Orange Book APPLICATION 203438 1

    19

    Ajanta 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 MONTELUKAST SODIUM, with a corresponding application number 203438.

    Regulatory Information RX

    With a dosage strength EQ 4MG BASE/PACKET

    Dosage Form Route GRANULE; ORAL

    Reference Listed Drug No

    Approved since 2015-07-31

    Therapeutic Equivalence (TE) Code AB

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