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 |
|---|
| 2020/04/06 |
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 |