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Exhibit Batch requirements for additional Strength in post approval scenario

  • 1.  Exhibit Batch requirements for additional Strength in post approval scenario

    This message was posted by a user wishing to remain anonymous
    Posted 20-Feb-2019 08:39
    This message was posted by a user wishing to remain anonymous

    With reference to an approved ANDA, filed prior to implementation of June 20, 2014 stability guideline - If I want to file an additional strength, Do I need to submit 3 exhibit batches with 6 months stability data or 1 exhibit batch with 3 month stability data is enough?


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