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 |
2014/02/27 |
SUPPL-88(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/10/31 |
SUPPL-87(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2012/10/31 |
SUPPL-86(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/02/28 |
SUPPL-85(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2011/06/10 |
SUPPL-82(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2011/02/02 |
SUPPL-84(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2010/06/30 |
SUPPL-81(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2009/03/09 |
SUPPL-80(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2007/12/07 |
SUPPL-79(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2007/05/29 |
SUPPL-78(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/04/17 |
SUPPL-61(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/11/04 |
SUPPL-76(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/06/13 |
SUPPL-77(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/04/07 |
SUPPL-75(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2003/10/17 |
SUPPL-73(补充) |
Approval |
Supplement |
PRIORITY
|
|
|
2002/09/23 |
SUPPL-70(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2002/09/20 |
SUPPL-71(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/02/14 |
SUPPL-67(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2002/01/30 |
SUPPL-68(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2001/10/22 |
SUPPL-69(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/08/01 |
SUPPL-65(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2001/06/26 |
SUPPL-66(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2001/04/26 |
SUPPL-64(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/04/26 |
SUPPL-62(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2000/09/14 |
SUPPL-60(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2000/08/22 |
SUPPL-59(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1999/03/11 |
SUPPL-55(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
1999/03/01 |
SUPPL-57(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1998/08/28 |
SUPPL-56(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1998/06/29 |
SUPPL-54(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1998/04/22 |
SUPPL-53(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1997/11/20 |
SUPPL-52(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1997/08/12 |
SUPPL-50(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1997/06/25 |
SUPPL-51(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1997/03/27 |
SUPPL-48(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1997/02/06 |
SUPPL-47(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1996/12/26 |
SUPPL-46(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1996/04/30 |
SUPPL-45(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1996/02/09 |
SUPPL-40(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1995/08/08 |
SUPPL-44(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1995/08/08 |
SUPPL-43(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1995/08/01 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1995/05/03 |
SUPPL-42(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
1995/02/08 |
SUPPL-34(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
1995/01/23 |
SUPPL-41(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1994/12/21 |
SUPPL-37(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1994/12/20 |
SUPPL-35(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1994/07/05 |
SUPPL-36(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1994/05/17 |
SUPPL-33(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1994/05/17 |
SUPPL-32(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1993/11/24 |
SUPPL-27(补充) |
Approval |
Labeling |
|
|
|
1993/11/23 |
SUPPL-28(补充) |
Approval |
Labeling |
|
|
|
1993/11/22 |
SUPPL-21(补充) |
Approval |
Labeling |
|
|
|
1993/08/09 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1992/12/17 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1992/11/27 |
SUPPL-30(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1992/04/15 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1991/12/19 |
SUPPL-17(补充) |
Approval |
Labeling |
|
|
|
1991/11/27 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1991/10/24 |
SUPPL-20(补充) |
Approval |
Labeling |
|
|
|
1991/08/28 |
SUPPL-12(补充) |
Approval |
Labeling |
|
|
|
1991/04/10 |
SUPPL-15(补充) |
Approval |
Labeling |
|
|
|
1991/03/28 |
SUPPL-18(补充) |
Approval |
Efficacy |
|
|
|
1991/03/12 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1991/02/21 |
SUPPL-10(补充) |
Approval |
Labeling |
|
|
|
1989/10/20 |
SUPPL-11(补充) |
Approval |
Labeling |
|
|
|
1989/03/21 |
SUPPL-7(补充) |
Approval |
Labeling |
|
|
|
1988/12/20 |
SUPPL-8(补充) |
Approval |
Labeling |
|
|
|
1988/12/14 |
SUPPL-9(补充) |
Approval |
Labeling |
|
|
|
1988/11/22 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1988/07/06 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1988/03/03 |
SUPPL-4(补充) |
Approval |
Labeling |
|
|
|
1988/03/01 |
SUPPL-1(补充) |
Approval |
Labeling |
|
|
|
1987/08/31 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
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 |