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 |
2021/12/22 |
SUPPL-119(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2016/07/22 |
SUPPL-101(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2016/07/07 |
SUPPL-99(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2016/06/08 |
SUPPL-98(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2016/04/21 |
SUPPL-97(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2016/03/03 |
SUPPL-96(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2015/10/30 |
SUPPL-95(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2015/08/10 |
SUPPL-94(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2015/03/09 |
SUPPL-92(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2014/09/05 |
SUPPL-91(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2014/02/27 |
SUPPL-90(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2013/10/30 |
SUPPL-89(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2013/07/31 |
SUPPL-88(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2005/03/03 |
SUPPL-66(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2002/11/13 |
SUPPL-55(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/10/09 |
SUPPL-56(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2002/06/14 |
SUPPL-53(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/08/13 |
SUPPL-49(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/08/13 |
SUPPL-42(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/08/13 |
SUPPL-41(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/05/08 |
SUPPL-51(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2001/05/07 |
SUPPL-50(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2000/11/14 |
SUPPL-48(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2000/10/27 |
SUPPL-47(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2000/09/11 |
SUPPL-45(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2000/08/31 |
SUPPL-46(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2000/07/10 |
SUPPL-44(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2000/04/10 |
SUPPL-43(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1999/12/08 |
SUPPL-40(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1999/10/22 |
SUPPL-38(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1999/10/05 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1999/09/22 |
SUPPL-34(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1999/09/07 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1999/07/28 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1999/07/26 |
SUPPL-35(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1999/02/11 |
SUPPL-27(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1999/01/04 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1998/11/18 |
SUPPL-32(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1998/06/17 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1998/06/12 |
SUPPL-30(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1998/06/12 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1998/03/23 |
SUPPL-28(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1998/01/30 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1997/12/07 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1997/08/08 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1997/07/31 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1997/07/16 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1997/03/03 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1996/12/20 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1996/12/12 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1996/10/22 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1996/09/23 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1996/09/20 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1996/06/05 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1996/05/31 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1996/04/18 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1996/04/08 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1996/02/23 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1995/12/06 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1995/07/24 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1995/06/19 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1995/05/08 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1995/05/03 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1995/04/07 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
;Orphan
|
|
|
1995/02/07 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1994/05/23 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
PRIORITY
;Orphan
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)