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 |
2013/12/03 |
SUPPL-136(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2013/10/30 |
SUPPL-137(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2000/01/24 |
SUPPL-125(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1999/05/14 |
SUPPL-124(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1999/02/04 |
SUPPL-123(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1997/07/30 |
SUPPL-122(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1995/08/30 |
SUPPL-120(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1994/12/13 |
SUPPL-121(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1994/02/04 |
SUPPL-118(补充) |
Approval |
Labeling |
|
|
|
1992/07/31 |
SUPPL-119(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1991/10/09 |
SUPPL-117(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1990/11/02 |
SUPPL-113(补充) |
Approval |
Labeling |
|
|
|
1990/09/19 |
SUPPL-116(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1990/08/15 |
SUPPL-115(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1986/07/17 |
SUPPL-110(补充) |
Approval |
Labeling |
|
|
|
1985/10/25 |
SUPPL-109(补充) |
Approval |
Labeling |
|
|
|
1985/04/16 |
SUPPL-108(补充) |
Approval |
Labeling |
|
|
|
1984/11/13 |
SUPPL-106(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1984/09/27 |
SUPPL-102(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1984/07/30 |
SUPPL-105(补充) |
Approval |
Labeling |
|
|
|
1984/06/12 |
SUPPL-104(补充) |
Approval |
Labeling |
|
|
|
1984/05/07 |
SUPPL-101(补充) |
Approval |
Labeling |
|
|
|
1984/03/06 |
SUPPL-97(补充) |
Approval |
Labeling |
|
|
|
1983/07/26 |
SUPPL-100(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1983/07/26 |
SUPPL-96(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1983/07/19 |
SUPPL-99(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1983/07/19 |
SUPPL-98(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1983/06/13 |
SUPPL-95(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1982/09/07 |
SUPPL-89(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1982/07/29 |
SUPPL-92(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1982/01/11 |
SUPPL-87(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1980/10/14 |
SUPPL-53(补充) |
Approval |
Labeling |
|
|
|
1979/07/18 |
SUPPL-82(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1979/07/18 |
SUPPL-79(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1978/11/06 |
SUPPL-75(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1978/11/06 |
SUPPL-74(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1978/05/26 |
SUPPL-73(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1977/07/01 |
SUPPL-55(补充) |
Approval |
Labeling |
|
|
|
1977/07/01 |
SUPPL-54(补充) |
Approval |
Labeling |
|
|
|
1977/06/14 |
SUPPL-61(补充) |
Approval |
Labeling |
|
|
|
1977/06/14 |
SUPPL-60(补充) |
Approval |
Labeling |
|
|
|
1977/06/14 |
SUPPL-59(补充) |
Approval |
Labeling |
|
|
|
1976/09/29 |
SUPPL-52(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1975/05/16 |
SUPPL-48(补充) |
Approval |
Labeling |
|
|
|
1975/05/16 |
SUPPL-46(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1975/05/16 |
SUPPL-43(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1975/05/16 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1975/05/16 |
SUPPL-37(补充) |
Approval |
Labeling |
|
|
|
1967/11/17 |
ORIG-1(原始申请) |
Approval |
Type 3 - New Dosage Form |
PRIORITY
|
|
|
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 |