Drugs

Activities Report of the Generic Drug Program (FY 2017)

GDUFA YEAR/Actions This Month16-Oct16-Nov16-Dec17-Jan17-Feb17-Mar17-Apr17-May17-Jun17-Jul17-Aug17-SepFY-2017
Refuse to Receive (RTR) + 9 824 17 19 *      77
Withdrawals (all original ANDAs) 9 1611 14 22 *      72
Approvals + 54 59 56 51 61 62      343
Tentative Approvals + 16 12 19 14 11 19      91
Complete Responses (CR) + 151 150 144 143 136 190      914
Drug Master File Completeness Assessment (DMF CA) 52 5088 117 99 *      406
GDUFA YEAR (Receipts)Submissions This Month16-Oct16-Nov16-Dec17-Jan17-Feb17-Mar17-Apr17-May17-Jun17-Jul17-Aug17-SepFY-2017
Abbreviated New Drug Applications (ANDA) ++108 81 235 57 58 197      736
CBE Supplements493 430530 497 451 *      2401
PAS Supplements43 2738 30 24 *      162
GDUFA YEAR (Receipts)Submissions This Month16-Oct16-Nov16-Dec17-Jan17-Feb17-Mar17-Apr17-May17-Jun17-Jul17-Aug17-SepFY-2017
Controls +++153 162 134 206 254 *      655
GDUFA Post CR Meeting Requests ++++178 180 181 183188 *       
Post CR Meeting Requests this month2 2 1 2 5 *      12

NOTE: Numbers reflect current data at the time of posting and may change based on refreshed counts in our tracking systems, including application status updates.
These numbers are not intended for Congressional reporting purposes.

* = This data requires additional verification and will be posted when available.
+ = Revised to reflect more accurate counting by our tracking systems. For example, RTRs revised to include both RTR due to failure to pay user fees and RTR due to technical reasons.
++ = Starting FY15, ANDA Original Receipts are reported as raw receipts (versus filed receipts).
+++ = Controls have been revised to count only those requests deemed appropriate for a control.
++++ = Cumulative and NOT specific to the month.

Page Last Updated: 04/06/2017
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