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Activities Report of the Generic Drug Program (FY 2017)
GDUFA YEAR/Actions This Month
16-Oct
16-Nov
16-Dec
17-Jan
17-Feb
17-Mar
17-Apr
17-May
17-Jun
17-Jul
17-Aug
17-Sep
FY-2017
Refuse to Receive (RTR) +
9
8
24
17
19
7
8
12
6
9
11
12
142
Withdrawals (all original ANDAs)
9
16
11
14
22
16
8
24
30
13
29
22
214
Approvals +
54
59
56
51
61
62
57
77
88
68
60
70
763
Tentative Approvals +
16
12
19
14
11
19
9
19
12
14
17
12
174
Complete Responses (CR) +
151
150
144
143
136
190
112
98
87
82
155
155
1603
Drug Master File Completeness Assessment (DMF CA)
52
50
88
117
99
97
44
67
62
57
39
48
820
GDUFA YEAR (Receipts)Submissions This Month
16-Oct
16-Nov
16-Dec
17-Jan
17-Feb
17-Mar
17-Apr
17-May
17-Jun
17-Jul
17-Aug
17-Sep
FY-2017
Abbreviated New Drug Applications (ANDA) ++
108
81
235
57
58
197
75
66
67
73
73
216
1306
CBE Supplements
493
430
530
497
451
618
586
690
532
440
549
508
6324
PAS Supplements
43
27
38
30
24
57
65
29
40
24
23
15
415
GDUFA YEAR (Receipts)Submissions This Month
16-Oct
16-Nov
16-Dec
17-Jan
17-Feb
17-Mar
17-Apr
17-May
17-Jun
17-Jul
17-Aug
17-Sep
FY-2017
Controls +++
153
162
134
206
254
258
224
274
286
235
256
225
2667
GDUFA Post CR Meeting Requests ++++
178
180
181
183
188
192
196
199
201
201
204
206
Post CR Meeting Requests this month
2
2
1
2
5
4
4
3
2
0
3
2
30
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.
