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    Approved Drug Products containing 209620 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 SOLUTION/DROPS;OPHTHALMIC (1)

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    01 RX (1)

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    01 AZELASTINE HYDROCHLORIDE (1)

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    01 No (1)

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    AZELASTINE HYDROCHLORIDE

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    SOLUTION/DROPS; OP...
    0.05%
    2019-03-20
    209620
    AZELASTINE HYDROCH...
    RX
    No
    AT
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    Looking for FDA Orange Book APPLICATION 209620

    Looking for FDA Orange Book APPLICATION 209620 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 AZELASTINE HYDROCHLORIDE, with a corresponding application number 209620.

    Regulatory Information RX

    With a dosage strength 0.05%

    Dosage Form Route SOLUTION/DROPS; OPHTHALMIC

    Reference Listed Drug No

    Approved since 2019-03-20

    Therapeutic Equivalence (TE) Code AT

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