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 |
2010/12/06 |
SUPPL-24(补充) |
Approval |
Labeling |
|
|
|
2009/05/27 |
SUPPL-22(补充) |
Approval |
Labeling |
|
|
|
2008/11/25 |
SUPPL-21(补充) |
Approval |
Labeling |
|
|
|
2008/11/19 |
SUPPL-20(补充) |
Approval |
Labeling |
|
|
|
2008/05/29 |
SUPPL-15(补充) |
Approval |
Labeling |
|
|
|
2002/10/22 |
SUPPL-14(补充) |
Approval |
Labeling |
|
|
|
2002/10/22 |
SUPPL-12(补充) |
Approval |
Labeling |
|
|
|
2002/09/26 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2001/05/15 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2001/02/27 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/05/05 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/10/16 |
SUPPL-6(补充) |
Approval |
Labeling |
|
|
|
1998/10/16 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/09/15 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/03/02 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/03/26 |
SUPPL-3(补充) |
Approval |
Labeling |
|
|
|
1990/10/01 |
SUPPL-2(补充) |
Approval |
Labeling |
|
|
|
1989/10/31 |
SUPPL-1(补充) |
Approval |
Labeling |
|
|
|
1988/12/08 |
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 |
与本品治疗等效的药品
活性成分:PERPHENAZINE 剂型/给药途径:TABLET;ORAL 规格:4MG 治疗等效代码:AB
申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
089684 |
001 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
4MG |
Prescription |
No |
No |
AB |
--
|
SANDOZ |
089685 |
003 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
4MG |
Prescription |
No |
No |
AB |
1988/12/08
|
SANDOZ |
040226 |
002 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
4MG |
Prescription |
No |
No |
AB |
1998/12/31
|
ENDO OPERATIONS |
205973 |
002 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
4MG |
Prescription |
No |
No |
AB |
2015/12/17
|
WILSHIRE PHARMS INC |
207582 |
002 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
4MG |
Prescription |
No |
No |
AB |
2016/10/17
|
WATSON LABS INC |
205056 |
002 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
4MG |
Prescription |
No |
No |
AB |
2019/03/01
|
RISING |
205232 |
002 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
4MG |
Prescription |
No |
No |
AB |
2020/04/06
|
ZYDUS PHARMS |
210163 |
002 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
4MG |
Prescription |
No |
No |
AB |
2022/05/18
|
APPCO |
212545 |
002 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
4MG |
Prescription |
No |
No |
AB |
2024/05/06
|
MACLEODS PHARMS LTD |