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Activities Report of the Generic Drug Program (FY 2016)
GDUFA YEAR/Actions This Month
15-Oct
15-Nov
15-Dec
16-Jan
16-Feb
16-Mar
16-Apr
16-May
16-Jun
16-Jul
16-Aug
16-Sep
FY-2016
Refuse to Receive (RTR) +
12
19
11
29
33
18
31
40
13
14
17
9
246
Withdrawals (all original ANDAs)
18
19
14
48
27
20
20
8
34
13
12
15
248
Approvals +
50
61
79
43
51
60
53
55
51
46
51
51
651
Tentative Approvals +
22
6
20
17
12
16
16
20
15
10
14
16
184
Complete Responses (CR) +
105
92
113
103
129
147
190
151
166
169
167
193
1725
Drug Master File Completeness Assessment (DMF CA)
111
57
132
61
96
65
84
60
51
83
38
48
886
GDUFA YEAR (Receipts)Submissions This Month
15-Oct
15-Nov
15-Dec
16-Jan
16-Feb
16-Mar
16-Apr
16-May
16-Jun
16-Jul
16-Aug
16-Sep
FY-2016
Abbreviated New Drug Applications (ANDA) ++
35
42
180
40
61
114
56
58
78
69
60
59
852
CBE Supplements
623
374
386
348
410
506
540
426
499
357
519
678
5666
PAS Supplements
34
33
47
32
45
35
33
43
39
33
71
33
478
GDUFA YEAR (Receipts)Submissions This Month
15-Oct
15-Nov
15-Dec
16-Jan
16-Feb
16-Mar
16-Apr
16-May
16-Jun
16-Jul
16-Aug
16-Sep
FY-2016
Controls +++
158
101
118
126
157
204
134
186
219
168
154
158
1883
GDUFA Post CR Meeting Requests ++++
141
143
146
148
153
156
161
163
166
169
174
176
Post CR Meeting Requests this month
1
2
3
2
5
3
5
2
3
3
5
2
36
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.
