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 |
2020/06/18 |
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:PROPAFENONE HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:225MG 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 |
021416 |
001 |
NDA |
RYTHMOL SR |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
225MG |
Discontinued |
Yes |
No |
AB |
2003/09/04
|
GLAXOSMITHKLINE LLC |
078540 |
001 |
ANDA |
PROPAFENONE HYDROCHLORIDE |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
225MG |
Prescription |
No |
No |
AB |
2010/10/18
|
STRIDES PHARMA |
202688 |
001 |
ANDA |
PROPAFENONE HYDROCHLORIDE |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
225MG |
Prescription |
No |
No |
AB |
2015/08/24
|
WATSON LABS INC |
205268 |
001 |
ANDA |
PROPAFENONE HYDROCHLORIDE |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
225MG |
Prescription |
No |
No |
AB |
2017/09/08
|
GLENMARK PHARMS LTD |
205956 |
001 |
ANDA |
PROPAFENONE HYDROCHLORIDE |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
225MG |
Prescription |
No |
No |
AB |
2018/07/02
|
RISING |
210339 |
001 |
ANDA |
PROPAFENONE HYDROCHLORIDE |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
225MG |
Prescription |
No |
No |
AB |
2019/01/04
|
SINOTHERAPEUTICS INC |
212928 |
001 |
ANDA |
PROPAFENONE HYDROCHLORIDE |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
225MG |
Prescription |
No |
No |
AB |
2020/06/18
|
TWI PHARMS |
212744 |
001 |
ANDA |
PROPAFENONE HYDROCHLORIDE |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
225MG |
Prescription |
No |
No |
AB |
2020/06/25
|
UPSHER SMITH LABS |
214184 |
001 |
ANDA |
PROPAFENONE HYDROCHLORIDE |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
225MG |
Prescription |
No |
No |
AB |
2021/04/21
|
ZYDUS LIFESCIENCES |
213096 |
001 |
ANDA |
PROPAFENONE HYDROCHLORIDE |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
225MG |
Prescription |
No |
No |
AB |
2023/02/21
|
AUROBINDO PHARMA LTD |
活性成分:PROPAFENONE HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:325MG 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 |
021416 |
002 |
NDA |
RYTHMOL SR |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
325MG |
Discontinued |
Yes |
No |
AB |
2003/09/04
|
GLAXOSMITHKLINE LLC |
078540 |
002 |
ANDA |
PROPAFENONE HYDROCHLORIDE |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
325MG |
Prescription |
No |
No |
AB |
2010/10/18
|
STRIDES PHARMA |
202688 |
002 |
ANDA |
PROPAFENONE HYDROCHLORIDE |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
325MG |
Prescription |
No |
No |
AB |
2015/08/24
|
WATSON LABS INC |
205268 |
002 |
ANDA |
PROPAFENONE HYDROCHLORIDE |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
325MG |
Prescription |
No |
No |
AB |
2017/09/08
|
GLENMARK PHARMS LTD |
205956 |
002 |
ANDA |
PROPAFENONE HYDROCHLORIDE |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
325MG |
Prescription |
No |
No |
AB |
2018/07/02
|
RISING |
210339 |
002 |
ANDA |
PROPAFENONE HYDROCHLORIDE |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
325MG |
Prescription |
No |
No |
AB |
2019/01/04
|
SINOTHERAPEUTICS INC |
212928 |
002 |
ANDA |
PROPAFENONE HYDROCHLORIDE |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
325MG |
Prescription |
No |
No |
AB |
2020/06/18
|
TWI PHARMS |
212744 |
002 |
ANDA |
PROPAFENONE HYDROCHLORIDE |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
325MG |
Prescription |
No |
No |
AB |
2020/06/25
|
UPSHER SMITH LABS |
214184 |
002 |
ANDA |
PROPAFENONE HYDROCHLORIDE |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
325MG |
Prescription |
No |
No |
AB |
2021/04/21
|
ZYDUS LIFESCIENCES |
213096 |
002 |
ANDA |
PROPAFENONE HYDROCHLORIDE |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
325MG |
Prescription |
No |
No |
AB |
2023/02/21
|
AUROBINDO PHARMA LTD |
活性成分:PROPAFENONE HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:425MG 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 |
021416 |
003 |
NDA |
RYTHMOL SR |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
425MG |
Discontinued |
Yes |
No |
AB |
2003/09/04
|
GLAXOSMITHKLINE LLC |
078540 |
003 |
ANDA |
PROPAFENONE HYDROCHLORIDE |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
425MG |
Prescription |
No |
Yes |
AB |
2010/10/18
|
STRIDES PHARMA |
202688 |
003 |
ANDA |
PROPAFENONE HYDROCHLORIDE |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
425MG |
Prescription |
No |
No |
AB |
2015/08/24
|
WATSON LABS INC |
205268 |
003 |
ANDA |
PROPAFENONE HYDROCHLORIDE |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
425MG |
Prescription |
No |
No |
AB |
2017/09/08
|
GLENMARK PHARMS LTD |
205956 |
003 |
ANDA |
PROPAFENONE HYDROCHLORIDE |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
425MG |
Prescription |
No |
No |
AB |
2018/07/02
|
RISING |
210339 |
003 |
ANDA |
PROPAFENONE HYDROCHLORIDE |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
425MG |
Prescription |
No |
No |
AB |
2019/01/04
|
SINOTHERAPEUTICS INC |
212928 |
003 |
ANDA |
PROPAFENONE HYDROCHLORIDE |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
425MG |
Prescription |
No |
No |
AB |
2020/06/18
|
TWI PHARMS |
212744 |
003 |
ANDA |
PROPAFENONE HYDROCHLORIDE |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
425MG |
Prescription |
No |
No |
AB |
2020/06/25
|
UPSHER SMITH LABS |
214184 |
003 |
ANDA |
PROPAFENONE HYDROCHLORIDE |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
425MG |
Prescription |
No |
No |
AB |
2021/04/21
|
ZYDUS LIFESCIENCES |
213096 |
003 |
ANDA |
PROPAFENONE HYDROCHLORIDE |
PROPAFENONE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
425MG |
Prescription |
No |
No |
AB |
2023/02/21
|
AUROBINDO PHARMA LTD |