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 |
2020/02/05 |
SUPPL-225(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/02/23 |
SUPPL-224(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2010/12/03 |
SUPPL-222(补充) |
Approval |
Labeling |
|
|
|
2009/07/21 |
SUPPL-221(补充) |
Approval |
Labeling |
|
|
|
2008/09/08 |
SUPPL-220(补充) |
Approval |
Labeling |
|
|
|
2008/08/19 |
SUPPL-217(补充) |
Approval |
Labeling |
|
|
|
2002/12/16 |
SUPPL-211(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2002/03/08 |
SUPPL-208(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2001/11/09 |
SUPPL-206(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2001/11/09 |
SUPPL-205(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2001/10/24 |
SUPPL-210(补充) |
Approval |
Labeling |
|
|
|
2001/10/24 |
SUPPL-209(补充) |
Approval |
Labeling |
|
|
|
2001/05/09 |
SUPPL-207(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/05/21 |
SUPPL-204(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/05/05 |
SUPPL-203(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/11/20 |
SUPPL-200(补充) |
Approval |
Labeling |
|
|
|
1998/11/20 |
SUPPL-199(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/10/08 |
SUPPL-201(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/08/20 |
SUPPL-202(补充) |
Approval |
Labeling |
|
|
|
1995/10/23 |
SUPPL-198(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/02/02 |
SUPPL-197(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/03/30 |
SUPPL-195(补充) |
Approval |
Labeling |
|
|
|
1989/11/09 |
SUPPL-194(补充) |
Approval |
Labeling |
|
|
|
1988/11/15 |
SUPPL-187(补充) |
Approval |
Labeling |
|
|
|
1988/11/15 |
SUPPL-186(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/11/15 |
SUPPL-185(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/11/15 |
SUPPL-184(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/11/15 |
SUPPL-183(补充) |
Approval |
Labeling |
|
|
|
1988/11/15 |
SUPPL-182(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/11/15 |
SUPPL-181(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/11/15 |
SUPPL-180(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/11/15 |
SUPPL-179(补充) |
Approval |
Labeling |
|
|
|
1988/11/15 |
SUPPL-177(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/11/15 |
SUPPL-176(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/11/15 |
SUPPL-175(补充) |
Approval |
Labeling |
|
|
|
1988/11/15 |
SUPPL-174(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/11/15 |
SUPPL-173(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/11/15 |
SUPPL-172(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/11/15 |
SUPPL-171(补充) |
Approval |
Labeling |
|
|
|
1988/11/15 |
SUPPL-170(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/11/15 |
SUPPL-169(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/08/26 |
SUPPL-193(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/08/26 |
SUPPL-192(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/08/26 |
SUPPL-191(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/08/26 |
SUPPL-190(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/08/26 |
SUPPL-189(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/07/15 |
SUPPL-168(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/02/25 |
SUPPL-167(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/02/25 |
SUPPL-165(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/02/25 |
SUPPL-164(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/02/25 |
SUPPL-162(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/02/25 |
SUPPL-161(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/02/25 |
SUPPL-159(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/02/25 |
SUPPL-158(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/02/25 |
SUPPL-156(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/02/25 |
SUPPL-155(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/02/25 |
SUPPL-153(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/05/29 |
SUPPL-152(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/01/02 |
SUPPL-151(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/01/02 |
SUPPL-150(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/01/02 |
SUPPL-149(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/01/02 |
SUPPL-148(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/02/08 |
SUPPL-144(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/02/08 |
SUPPL-140(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/02/08 |
SUPPL-139(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/11/21 |
SUPPL-143(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/11/21 |
SUPPL-142(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/11/21 |
SUPPL-138(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/12/16 |
SUPPL-136(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/04/12 |
SUPPL-132(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/04/12 |
SUPPL-131(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/08/11 |
SUPPL-130(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/06/18 |
SUPPL-129(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/06/18 |
SUPPL-128(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/06/18 |
SUPPL-100(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1973/01/03 |
ORIG-1(原始申请) |
Approval |
|
|
|
|
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 |