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  • 1.  Proprietary Names for OTC ANDA's

    Posted 17-Jul-2014 12:39
    Hello,
    We would like to propose proprietary names for our distributors of OTC ANDA's. We have many distributors and most of them would like to have their proprietary name for their product.

    I am not sure we can submit many proprietary names for one ANDA (OTC). Is it possible? if yes what's the process?

    I have seen couple of allergy products in market which refer to the same OTC ANDA but every store has its own proprietary name. Do we need FDA approval for every proprietary name?

    Please help

    Thank you 
    -------------------------------------------
    BALAJI GANDHE RAC
    DES PLAINES IL
    United States
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  • 2.  RE: Proprietary Names for OTC ANDA's

    This message was posted by a user wishing to remain anonymous
    Posted 23-Jan-2023 09:11
    This message was posted by a user wishing to remain anonymous

    I am running into a similar situation now. Did you ever get a response or learn the answer to this question?