; (2) the number of applications filed under section 505(j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j) ) awaiting action by the Secretary, including such applications that were filed prior to October 1, 2014; (3) the number of applications filed under section 505(j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j) ) and prior approval supplements withdrawn in each month covered by the report; (4) the mean and median approval and tentative approval times for applications covered by the report; (5) the number of applications described in paragraphs (1), (2), and (3) that are subject to priority review