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  • 1.  Labeling for Different Formulations

    This message was posted by a user wishing to remain anonymous
    Posted 15-Aug-2018 09:48
    This message was posted by a user wishing to remain anonymous

    Dear Forum-

    If a drug product has two formulations - Immediate Release and Delayed Release, can both formulations be in 1 label or would it require 2 separate labels?

    Thank you so much for your advice.


  • 2.  RE: Labeling for Different Formulations

    Posted 15-Aug-2018 10:40
    They will need two separate labeling.
    It is also an easier way to handle changes when they are just for one formulation.

    Vini

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    Vini Modi, MS
    RA/Compliance
    PA
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    Original Message


  • 3.  RE: Labeling for Different Formulations

    Posted 15-Aug-2018 12:56
    FDA would ask you to submit two separate NDAs because they are two different dosage forms (immediate release-IR and Delayed release) so you will need two different labels for submission. Hope this helps!

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    GRSAOnline
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    Original Message


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