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 |
2017/02/23 |
SUPPL-1(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/12/17 |
ORIG-1(原始申请) |
Approval |
|
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 |
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:2MG 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 |
089683 |
001 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
--
|
SANDOZ |
089685 |
002 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
1988/12/08
|
SANDOZ |
040226 |
001 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
1998/12/31
|
ENDO OPERATIONS |
205973 |
001 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2015/12/17
|
WILSHIRE PHARMS INC |
207582 |
001 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2016/10/17
|
WATSON LABS INC |
205056 |
001 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2019/03/01
|
RISING |
205232 |
001 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2020/04/06
|
ZYDUS PHARMS |
210163 |
001 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2022/05/18
|
APPCO |
212545 |
001 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2024/05/06
|
MACLEODS PHARMS LTD |
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 |
活性成分:PERPHENAZINE 剂型/给药途径:TABLET;ORAL 规格:8MG 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 |
089685 |
001 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
8MG |
Prescription |
No |
No |
AB |
1988/12/08
|
SANDOZ |
040226 |
003 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
8MG |
Prescription |
No |
No |
AB |
1998/12/31
|
ENDO OPERATIONS |
205973 |
003 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
8MG |
Prescription |
No |
No |
AB |
2015/12/17
|
WILSHIRE PHARMS INC |
207582 |
003 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
8MG |
Prescription |
No |
No |
AB |
2016/10/17
|
WATSON LABS INC |
205056 |
003 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
8MG |
Prescription |
No |
No |
AB |
2019/03/01
|
RISING |
205232 |
003 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
8MG |
Prescription |
No |
No |
AB |
2020/04/06
|
ZYDUS PHARMS |
210163 |
003 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
8MG |
Prescription |
No |
No |
AB |
2022/05/18
|
APPCO |
212545 |
003 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
8MG |
Prescription |
No |
No |
AB |
2024/05/06
|
MACLEODS PHARMS LTD |
活性成分:PERPHENAZINE 剂型/给药途径:TABLET;ORAL 规格:16MG 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 |
089686 |
001 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
16MG |
Prescription |
Yes |
No |
AB |
--
|
SANDOZ |
089685 |
004 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
16MG |
Prescription |
No |
Yes |
AB |
1988/12/08
|
SANDOZ |
040226 |
004 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
16MG |
Prescription |
No |
No |
AB |
1998/12/31
|
ENDO OPERATIONS |
205973 |
004 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
16MG |
Prescription |
No |
No |
AB |
2015/12/17
|
WILSHIRE PHARMS INC |
207582 |
004 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
16MG |
Prescription |
No |
No |
AB |
2016/10/17
|
WATSON LABS INC |
205056 |
004 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
16MG |
Prescription |
No |
No |
AB |
2019/03/01
|
RISING |
205232 |
004 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
16MG |
Prescription |
No |
No |
AB |
2020/04/06
|
ZYDUS PHARMS |
210163 |
004 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
16MG |
Prescription |
No |
No |
AB |
2022/05/18
|
APPCO |
212545 |
004 |
ANDA |
PERPHENAZINE |
PERPHENAZINE |
TABLET;ORAL |
16MG |
Prescription |
No |
No |
AB |
2024/05/06
|
MACLEODS PHARMS LTD |