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Can the addition of an intermediate strength

Customer Question

Can the addition of an intermediate strength for a weight-proportion filled, controlled release capsule be filed as CBE30 providing 3months stability data is available?
Submitted: 1 year ago.
Category: Legal
Expert:  Briarcliff767 replied 1 year ago.

Hi my name is ***** ***** I am happy to assist you. It can so long as the manufacture of the capsule informs that FDA of any changes to their approved capsule. It will have to fall into their regulations that are stated on their pre market approval process. Please let me know if you have further questions. Hope

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