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Changes to an approved ANDA - debossing to be replaced by imprinting

  • 1.  Changes to an approved ANDA - debossing to be replaced by imprinting

    Posted 07-Nov-2018 03:01

    Hi 

    The approved ANDA as well as the RLD is having debossing on the tablet. 
    Now we would like to go for imprinting on the tablet (with the same identification mark)  instead of debossing. 
    Is it acceptable to proceed for this change, any guidance / experience, please ..

    Regards,

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    Mir Hossain
    Square Pharmaceuticals Ltd.

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