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Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance
GDUFA YEAR/Actions This Month
17-Oct
17-Nov
17-Dec
18-Jan
18-Feb
18-Mar
18-Apr
18-May
18-Jun
18-Jul
18-Aug
18-Sep
FY-2018
Refuse to Receive (RTR) - Originals
10
30
18
11
9
9
5
8
11
5
7
4
127
Standard - GDUFA II
0
1
2
6
6
1
2
4
4
1
4
2
33
Priority - GDUFA II
0
5
5
3
3
6
3
4
7
3
3
2
44
GDUFA I
10
24
11
2
0
2
0
0
0
1
0
0
50
Acknowledgement - Original
66
161
63
51
105
86
57
136
72
70
84
103
1054
Refuse to Receive (RTR) - PAS
1
1
1
2
2
0
1
0
0
0
0
0
8
Withdrawals (all original ANDAs)
37
96
13
90
146
43
12
29
27
11
44
58
606
Approved ANDA
26
85
0
67
129
23
3
18
12
0
31
48
442
Unapproved ANDA
11
11
13
23
17
20
9
11
15
11
13
10
164
Withdrawals (PAS)
5
5
9
4
11
10
8
6
0
7
9
7
81
Approvals
87
84
78
25
32
57
66
67
74
96
53
62
781
First Cycle Approvals (included above)
26
13
20
11
7
7
13
7
11
16
6
5
142
Tentative Approvals
14
23
20
6
5
11
16
19
18
30
15
13
190
First Cycle Tentative Approvals (included above)
2
4
1
1
1
3
1
2
3
4
2
0
24
Complete Responses (CR)
325
240
242
307
185
159
142
185
217
357
156
133
2648
Information Requests (IR)
267
328
263
457
390
429
362
449
391
325
436
355
4452
Originals
185
231
190
360
297
321
280
344
283
217
323
261
3292
Supplements
82
97
73
97
93
108
82
105
108
108
113
94
1160
Discipline Review Letters (DRL)
108
81
88
35
80
224
149
216
322
198
248
299
2048
Drug Master File Completeness Assessment (DMF CA)
50
59
48
64
47
89
49
48
45
49
53
58
659
GDUFA YEAR (Receipts)Submissions This Month
17-Oct
17-Nov
17-Dec
18-Jan
18-Feb
18-Mar
18-Apr
18-May
18-Jun
18-Jul
18-Aug
18-Sep
FY-2018
Abbreviated New Drug Applications (ANDA) +
65
50
131
91
56
139
83
57
85
91
97
99
1044
ANDA Amendments
156
163
168
139
177
191
218
232
202
241
271
199
2357
Major
60
71
73
58
77
84
98
107
108
117
123
102
1078
Minor
88
90
94
80
100
105
115
124
92
120
146
96
1250
Unsolicited Amendment
8
2
1
1
0
2
5
1
2
4
2
1
29
Pre-Submission Facility Correspondence
5
1
5
8
9
6
5
6
1
6
7
8
67
CBE Supplements
580
657
475
453
496
361
651
574
675
512
575
479
6488
PAS Supplements
83
46
65
54
50
179
200
92
70
94
92
78
1103
DMFs - Type II
64
56
81
66
31
85
46
43
41
53
55
62
683
GDUFA YEAR (Receipts)
17-Oct
17-Nov
17-Dec
18-Jan
18-Feb
18-Mar
18-Apr
18-May
18-Jun
18-Jul
18-Aug
18-Sep
FY-2018
Controls ++
233
252
239
238
238
228
250
252
266
264
253
220
2933
Requests for Clarification
0
0
4
0
0
3
1
2
6
0
5
5
26
GDUFA Post CR Meeting Requests +++
214
225
227
236
253
259
259
264
268
273
282
285
Post CR Meeting Requests This month
8
11
2
9
17
6
0
5
4
5
9
3
79
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.
+ = ANDA Original Receipts are reported as raw receipts (versus filed receipts).
++ = Controls count only those requests deemed appropriate for a control.
+++ = Cumulative and NOT specific to the month.
