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标题: 201410:FDA2014财年ANDA仿制药报告 [打印本页]
作者: ZGZG    时间: 2014-10-31 11:00 AM
标题: 201410:FDA2014财年ANDA仿制药报告
201410:FDA2014财年ANDA仿制药报告  

2014-10-29 07:48:03|  分类： FDA|举报|字号 [url=]订阅[/url]





Activities Report of the Generic Drug Program (FY 2014)
Actions This MonthOct-13Nov-13Dec-13Jan-14Feb-14Mar-14Apr-14May-14Jun-14Jul-14Aug-14Sep-14FY-2014
Refuse to Receive (RTR)
30
10
16
16
14
8
7
20
12
9
10
21
173

Withdrawals
19
7
5
13
7
11
8
4
17
17
36
35
179

Approvals
20
40
30
34
34
38
41
20
44
18
45
45
409

Tentative Approvals
4
10
12
5
7
7
7
9
10
6
7
7
91

Complete Responses (CR)
113
126
111
114
118
112
100
120
90
87
88
75
1254

Drug Master File Complete Assessment (DMF CA)
181
150
98
192
129
130
105
156
173
160
130
102
1706


Submissions This MonthOct-13Nov-13Dec-13Jan-14Feb-14Mar-14Apr-14May-14Jun-14Jul-14Aug-14Sep-14FY-2014
Abbreviated New Drug Applications (ANDA)
41
58
225
85
76
112
74
134
635
4
4
25
1473

Amendments - Originals
176
156
143
139
131
160
155
153
115
134
152
164
1778

To Backlog ANDAs
152
123
114
117
109
128
122
111
67
97
102
115
1357

To Cohort Yr 1 ANDAs
22
27
25
18
15
26
22
22
17
13
17
18
242

To Cohort Yr 2 ANDAs
2
6
4
4
7
6
11
20
31
24
32
31
179

Amendments - Supplements
216
188
266
264
192
241
264
225
212
297
298
225
2888

To Backlog Prior Approval Supplements (PAS)
28
21
26
59
35
37
44
29
35
37
44
24
419

To Cohort Yr 1 PASs
15
10
2
10
3
9
18
19
11
20
16
9
142

To Cohort Yr 2 PASs
27
18
38
28
33
39
36
37
33
41
44
44
418

Tier Amendments
0
0
0
0
0
0
0
0
0
0
0
0
0

Tier 1A
0
0
0
0
0
0
0
0
0
0
0
0
0

Tier 1B
0
0
0
0
0
0
0
0
0
0
0
0
0

Tier 1C
0
0
0
0
0
0
0
0
0
0
0
0
0

Tier 2
0
0
0
0
0
0
0
0
0
0
0
0
0

Drug Master Files (DMF)
64
75
102
83
69
131
92
78
103
80
74
88
1039

Controls
81
90
60
108
76
112
94
66
99
112
101
109
1087

GDUFA Post CR Meeting Requests *
25
29
46
49
54
58
63
66
74
77
80
85
717


Status NumberOct-13Nov-13Dec-13Jan-14Feb-14Mar-14Apr-14May-14Jun-14Jul-14Aug-14Sep-14FY-2014
Canceled
2
2
3
3
3
3
3
3
3
3
3
3
36

Complete
14
15
17
22
27
30
35
38
43
50
58
60
504

Denied
2
2
3
3
3
4
5
5
5
5
8
8
73

Granted
0
1
4
3
3
3
2
2
5
1
3
3
14

Pending
7
8
8
9
10
8
7
8
8
8
8
11
90

Post CR Meeting Requests This month
6
3
8
3
6
4
4
3
6
3
3
5
62


* = Cumulative and NOT specific to the month
Numbers are rounded and do not reflect actual numbers for Congressional reporting purposes

201410:FDA2014财年ANDA仿制药报告 - Julia的日志 - 网易博客
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