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 |
2017/01/30 |
SUPPL-47(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/05/04 |
SUPPL-46(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/02/16 |
SUPPL-45(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/02/18 |
SUPPL-43(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/12/20 |
SUPPL-44(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/11/18 |
SUPPL-41(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/06/21 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/06/11 |
SUPPL-40(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/05/13 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/05/10 |
SUPPL-38(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/03/15 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2008/11/10 |
SUPPL-30(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/03/27 |
SUPPL-28(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2004/10/15 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2003/01/16 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/04/19 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/03/04 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/12/29 |
SUPPL-19(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/04/14 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/11/20 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/02/18 |
SUPPL-16(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1997/06/18 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/03/21 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/08/20 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/07/16 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/03/26 |
SUPPL-10(补充) |
Approval |
Labeling |
|
|
|
1982/06/30 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/05/07 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/07/24 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1977/08/23 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1977/07/27 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/10/08 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1973/11/23 |
ORIG-1(原始申请) |
Approval |
Type 5 - New Formulation or New Manufacturer |
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 |