Tentative expiration dating period

A tentative expiration dating period of up to 24 months will be granted based on satisfactory accelerated stability data unless not supported by the available long-term stability data... 

Additional stability studies (12 months at the intermediate conditions or long-term data through the proposed expiration date) if significant change is seen after 3 months during the accelerated stability study the tentative expiration dating period will be determined on the basis of the available data from the additional study... 

Alternatively, if the stability study on at least three pilot-scale batches is continued after the NDA/BLA approval, it is feasible to extend the tentative expiration dating period based on full long-term data obtained from these batches in accordance with the approved protocol, including statistical analysis if appropriate, through a Prior Approval Supplement. However, the expiration dating period thus derived remains tentative until confirmed with full long-term data from at least three production batches. 

Tentative Expiration Dating Period — Provisional expiration dating period that is based on acceptable accelerated data, statistical analysis of available long-term data, and other supportive data for an NDA product, or on acceptable accelerated data for an ANDA product but not on full longterm stability data from at least three production batches. 

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