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 |
2000/01/24 |
SUPPL-181(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1999/05/14 |
SUPPL-180(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/02/04 |
SUPPL-179(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/07/30 |
SUPPL-178(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1995/08/30 |
SUPPL-176(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1994/12/13 |
SUPPL-177(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1994/02/04 |
SUPPL-174(补充) |
Approval |
Labeling |
|
|
|
1992/07/31 |
SUPPL-175(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1991/10/09 |
SUPPL-173(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1990/11/02 |
SUPPL-169(补充) |
Approval |
Labeling |
|
|
|
1990/09/19 |
SUPPL-172(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1990/08/06 |
SUPPL-171(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/10/22 |
SUPPL-166(补充) |
Approval |
Labeling |
|
|
|
1986/07/17 |
SUPPL-165(补充) |
Approval |
Labeling |
|
|
|
1985/10/25 |
SUPPL-164(补充) |
Approval |
Labeling |
|
|
|
1985/10/25 |
SUPPL-163(补充) |
Approval |
Labeling |
|
|
|
1985/06/19 |
SUPPL-162(补充) |
Approval |
Labeling |
|
|
|
1985/04/16 |
SUPPL-161(补充) |
Approval |
Labeling |
|
|
|
1984/11/13 |
SUPPL-159(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/09/27 |
SUPPL-155(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/07/30 |
SUPPL-158(补充) |
Approval |
Labeling |
|
|
|
1984/06/12 |
SUPPL-157(补充) |
Approval |
Labeling |
|
|
|
1984/05/07 |
SUPPL-154(补充) |
Approval |
Labeling |
|
|
|
1984/03/06 |
SUPPL-50(补充) |
Approval |
Labeling |
|
|
|
1983/07/26 |
SUPPL-53(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1983/07/26 |
SUPPL-49(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1983/07/19 |
SUPPL-52(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1983/07/19 |
SUPPL-51(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1983/06/13 |
SUPPL-48(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/09/07 |
SUPPL-42(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/07/29 |
SUPPL-145(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/01/11 |
SUPPL-40(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/07/18 |
SUPPL-133(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/07/18 |
SUPPL-130(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/07/18 |
SUPPL-129(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/07/18 |
SUPPL-128(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/11/06 |
SUPPL-127(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/11/06 |
SUPPL-126(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/05/26 |
SUPPL-125(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1977/11/22 |
SUPPL-104(补充) |
Approval |
Labeling |
|
|
|
1977/11/22 |
SUPPL-103(补充) |
Approval |
Labeling |
|
|
|
1977/07/01 |
SUPPL-85(补充) |
Approval |
Labeling |
|
|
|
1977/06/14 |
SUPPL-100(补充) |
Approval |
Labeling |
|
|
|
1977/06/14 |
SUPPL-99(补充) |
Approval |
Labeling |
|
|
|
1977/06/14 |
SUPPL-98(补充) |
Approval |
Labeling |
|
|
|
1977/06/14 |
SUPPL-95(补充) |
Approval |
Labeling |
|
|
|
1977/06/14 |
SUPPL-92(补充) |
Approval |
Labeling |
|
|
|
1977/05/26 |
SUPPL-97(补充) |
Approval |
Labeling |
|
|
|
1977/05/26 |
SUPPL-96(补充) |
Approval |
Labeling |
|
|
|
1977/05/26 |
SUPPL-87(补充) |
Approval |
Labeling |
|
|
|
1977/05/26 |
SUPPL-86(补充) |
Approval |
Labeling |
|
|
|
1975/05/16 |
SUPPL-82(补充) |
Approval |
Labeling |
|
|
|
1975/05/16 |
SUPPL-80(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1975/05/16 |
SUPPL-78(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1975/05/16 |
SUPPL-74(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1975/05/16 |
SUPPL-72(补充) |
Approval |
Labeling |
|
|
|
1964/03/05 |
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 |