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  7. Activities Report of the Generic Drug Program (FY 2017)
  1. Types of Applications

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 7 8 12 6 9 11 12142
Withdrawals (all original ANDAs) 9 1611 14 22 16 8 24 30 13 29 22214
Approvals + 54 59 56 51 61 62 57 77 88 68 60 70763
Tentative Approvals + 16 12 19 14 11 19 9 19 12 14 17 12174
Complete Responses (CR) + 151 150 144 143 136 190 112 98 87 82 155 1551603
Drug Master File Completeness Assessment (DMF CA) 52 5088 117 99 9744 67 62 57 39 48820
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 75 66 67 73 73 2161306
CBE Supplements493 430530 497 451 618586 690 532 440 549 5086324
PAS Supplements43 2738 30 24 5765 29 40 24 23 15415
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 258224 274 286 235 256 2252667
GDUFA Post CR Meeting Requests ++++178 180 181 183188 192196 199 201 201 204 206 
Post CR Meeting Requests this month2 2 1 2 5 44 3 2 0 3 230

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.

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