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 |
2014/05/09 |
SUPPL-86(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/04/07 |
SUPPL-85(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/01/15 |
SUPPL-84(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1999/08/26 |
SUPPL-67(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1999/08/26 |
SUPPL-64(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1998/11/05 |
SUPPL-66(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/06/12 |
SUPPL-65(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/03/18 |
SUPPL-63(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/07/17 |
SUPPL-59(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/07/09 |
SUPPL-62(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/06/26 |
SUPPL-58(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/02/02 |
SUPPL-61(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1995/08/17 |
SUPPL-56(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1995/08/03 |
SUPPL-60(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1993/11/03 |
SUPPL-55(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1992/05/01 |
SUPPL-48(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1992/01/28 |
SUPPL-53(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1991/09/10 |
SUPPL-52(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1991/08/30 |
SUPPL-54(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1990/02/22 |
SUPPL-49(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1990/01/11 |
SUPPL-50(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1989/09/13 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/12/15 |
SUPPL-41(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/11/26 |
SUPPL-45(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/08/08 |
SUPPL-44(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/01/31 |
SUPPL-40(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/11/01 |
SUPPL-38(补充) |
Approval |
Labeling |
|
|
|
1985/11/01 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/10/29 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/10/26 |
SUPPL-39(补充) |
Approval |
Labeling |
|
|
|
1985/10/26 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/09/26 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/06/10 |
SUPPL-43(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/05/10 |
SUPPL-42(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/05/03 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/11/28 |
SUPPL-28(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/10/22 |
SUPPL-32(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/10/17 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/10/10 |
SUPPL-18(补充) |
Approval |
Labeling |
|
|
|
1984/10/10 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/04/09 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/03/21 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/03/01 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/02/17 |
SUPPL-19(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1983/12/08 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1983/09/06 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1983/06/16 |
SUPPL-21(补充) |
Approval |
Labeling |
|
|
|
1983/02/15 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/11/05 |
SUPPL-12(补充) |
Approval |
Labeling |
|
|
|
1982/11/05 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/07/26 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/07/08 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/06/09 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/02/01 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/01/08 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/10/01 |
SUPPL-6(补充) |
Approval |
Labeling |
|
|
|
1981/05/16 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/04/22 |
SUPPL-3(补充) |
Approval |
Labeling |
|
|
|
1981/04/21 |
SUPPL-5(补充) |
Approval |
Labeling |
|
|
|
1981/04/21 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/12/19 |
ORIG-1(原始申请) |
Approval |
Type 4 - New Combination |
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 |