批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期 | 提交类型 | 提交号 | 审批结论 | 申请内容分类 | 审评优先级;罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
1997/08/22 |
Supplemental |
74 |
Approval |
Labeling |
STANDARD |
|
|
1995/09/22 |
Supplemental |
69 |
Approval |
Labeling |
STANDARD |
|
|
1995/09/22 |
Supplemental |
68 |
Approval |
Labeling |
STANDARD |
|
|
1994/12/12 |
Supplemental |
71 |
Approval |
Labeling |
STANDARD |
|
|
1994/12/12 |
Supplemental |
70 |
Approval |
Labeling |
STANDARD |
|
|
1994/12/07 |
Supplemental |
33 |
Approval |
Labeling |
STANDARD |
|
|
1993/01/07 |
Supplemental |
67 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1992/09/22 |
Supplemental |
65 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1992/08/11 |
Supplemental |
66 |
Approval |
Labeling |
STANDARD |
|
|
1991/10/24 |
Supplemental |
60 |
Approval |
Labeling |
STANDARD |
|
|
1991/09/10 |
Supplemental |
63 |
Approval |
Labeling |
STANDARD |
|
|
1991/03/06 |
Supplemental |
57 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1990/05/25 |
Supplemental |
59 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1990/03/05 |
Supplemental |
58 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1990/02/02 |
Supplemental |
56 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1990/01/22 |
Supplemental |
54 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1989/11/28 |
Supplemental |
55 |
Approval |
Labeling |
STANDARD |
|
|
1989/03/02 |
Supplemental |
42 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1989/02/23 |
Supplemental |
50 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1988/12/01 |
Supplemental |
49 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1988/10/11 |
Supplemental |
48 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1988/08/26 |
Supplemental |
47 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1988/08/26 |
Supplemental |
46 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1988/07/14 |
Supplemental |
45 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1988/07/14 |
Supplemental |
44 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1988/07/14 |
Supplemental |
43 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1988/06/29 |
Supplemental |
40 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1988/03/25 |
Supplemental |
39 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1988/03/18 |
Supplemental |
38 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1988/02/16 |
Supplemental |
36 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1988/01/05 |
Supplemental |
37 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1987/11/19 |
Supplemental |
35 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1987/11/19 |
Supplemental |
34 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1987/09/18 |
Supplemental |
30 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1986/09/19 |
Supplemental |
26 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1986/03/12 |
Supplemental |
25 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1986/02/25 |
Supplemental |
27 |
Approval |
Labeling |
STANDARD |
|
|
1986/01/24 |
Supplemental |
28 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1985/11/26 |
Supplemental |
23 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1985/11/01 |
Supplemental |
22 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1985/09/12 |
Supplemental |
24 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1984/12/21 |
Supplemental |
21 |
Approval |
Labeling |
STANDARD |
|
|
1984/06/14 |
Supplemental |
16 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1984/05/11 |
Supplemental |
17 |
Approval |
Labeling |
STANDARD |
|
|
1983/11/30 |
Supplemental |
14 |
Approval |
Labeling |
STANDARD |
|
|
1983/06/24 |
Supplemental |
13 |
Approval |
Labeling |
STANDARD |
|
|
1982/08/16 |
Supplemental |
12 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1982/07/26 |
Supplemental |
11 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1982/06/16 |
Supplemental |
10 |
Approval |
Manufacturing (CMC) |
STANDARD |
|
|
1981/07/08 |
Supplemental |
9 |
Approval |
Labeling |
STANDARD |
|
|
1977/02/17 |
Supplemental |
5 |
Approval |
Labeling |
STANDARD |
|
|
1973/08/03 |
Original(原始申请) |
1 |
Approval |
Type 3 - New Dosage Form |
STANDARD |
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号 | 专利号 | 专利过期日 | 是否物质专利 | 是否产品专利 | 专利用途代码 | 撤销请求 | 提交日期 | 专利下载 | 备注 |
无 |