Drugs

Activities Report of the Generic Drug Program (FY 2016)

GDUFA YEAR/Actions This Month15-Oct15-Nov15-Dec16-Jan16-Feb16-Mar16-Apr16-May16-Jun16-Jul16-Aug16-SepFY-2016
Refuse to Receive (RTR) +12 19 11 29 33 18      122
Withdrawals (all original ANDAs)18 19 14 48 27 20      146
Approvals +50 61 79 43 51 62      346
Tentative Approvals +22 6 20 17 12 16      93
Complete Responses (CR) +105 92 113 103 129 147      689
Drug Master File Completeness Assessment (DMF CA)111 57 132 61 96 65      522
GDUFA YEAR (Receipts)Submissions This Month15-Oct15-Nov15-Dec16-Jan16-Feb16-Mar16-Apr16-May16-Jun16-Jul16-Aug16-SepFY-2016
Abbreviated New Drug Applications (ANDA) ++35 42 180 40 61 114      472
CBE Supplements623 374 386 348 410 506      2647
PAS Supplements34 33 47 32 45 35      226
GDUFA YEAR (Receipts)Submissions This Month15-Oct15-Nov15-Dec16-Jan16-Feb16-Mar16-Apr16-May16-Jun16-Jul16-Aug16-SepFY-2016
Controls +++158 101 118 126 157 204      864
GDUFA Post CR Meeting Requests ++++141 143 146 148 153 156       
Post CR Meeting Requests this month1 2 3 2 5 3      16

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: 05/03/2016
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