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    Approved Drug Products containing 213508 listed in the FDA Orange Book. Original Data : FDA Website

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    Alembic Pharmaceuticals Limited

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    01 ALEMBIC (1)

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    01 GEL;TOPICAL (1)

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    01 ADAPALENE (1)

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    ADAPALENE

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    GEL; TOPICAL
    0.3%
    2020-06-18
    213508
    ADAPALENE
    RX
    No
    AB
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    Looking for FDA Orange Book APPLICATION 213508

    Looking for FDA Orange Book APPLICATION 213508 1

    19

    Alembic Pharmaceuticals 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 ADAPALENE, with a corresponding application number 213508.

    Regulatory Information RX

    With a dosage strength 0.3%

    Dosage Form Route GEL; TOPICAL

    Reference Listed Drug No

    Approved since 2020-06-18

    Therapeutic Equivalence (TE) Code AB

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