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 |
|---|
| 2012/05/23 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2011/11/28 |
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:FELODIPINE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:2.5MG 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 |
|---|
| 075896 |
001 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
2.5MG |
Discontinued |
No |
No |
AB |
2004/11/02
|
SUN PHARM INDUSTRIES |
| 090365 |
001 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2010/12/17
|
GLENMARK PHARMS LTD |
| 200815 |
001 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2011/10/28
|
ENDO OPERATIONS |
| 202170 |
001 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2011/11/28
|
TORRENT PHARMS LTD |
| 203417 |
001 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2013/01/17
|
AUROBINDO PHARMA LTD |
| 201964 |
001 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2013/11/08
|
HERITAGE |
| 091200 |
001 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2013/12/13
|
SUN PHARM INDS LTD |
| 203032 |
001 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2015/05/21
|
ORBION PHARMS |
| 210847 |
001 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2018/10/26
|
YILING |
| 204800 |
001 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2019/04/29
|
YUNG SHIN PHARM |
活性成分:FELODIPINE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:5MG 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 |
|---|
| 075896 |
002 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
5MG |
Discontinued |
No |
No |
AB |
2004/11/02
|
SUN PHARM INDUSTRIES |
| 090365 |
002 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
5MG |
Prescription |
No |
No |
AB |
2010/12/17
|
GLENMARK PHARMS LTD |
| 200815 |
002 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
5MG |
Prescription |
No |
No |
AB |
2011/10/28
|
ENDO OPERATIONS |
| 202170 |
002 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
5MG |
Prescription |
No |
No |
AB |
2011/11/28
|
TORRENT PHARMS LTD |
| 203417 |
002 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
5MG |
Prescription |
No |
No |
AB |
2013/01/17
|
AUROBINDO PHARMA LTD |
| 201964 |
002 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
5MG |
Prescription |
No |
No |
AB |
2013/11/08
|
HERITAGE |
| 091200 |
002 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
5MG |
Prescription |
No |
No |
AB |
2013/12/13
|
SUN PHARM INDS LTD |
| 203032 |
002 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
5MG |
Prescription |
No |
No |
AB |
2015/05/21
|
ORBION PHARMS |
| 210847 |
002 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
5MG |
Prescription |
No |
No |
AB |
2018/10/26
|
YILING |
| 204800 |
002 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
5MG |
Prescription |
No |
No |
AB |
2019/04/29
|
YUNG SHIN PHARM |
活性成分:FELODIPINE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:10MG 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 |
|---|
| 075896 |
003 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
10MG |
Discontinued |
No |
No |
AB |
2004/11/02
|
SUN PHARM INDUSTRIES |
| 090365 |
003 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2010/12/17
|
GLENMARK PHARMS LTD |
| 200815 |
003 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2011/10/28
|
ENDO OPERATIONS |
| 202170 |
003 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
10MG |
Prescription |
No |
Yes |
AB |
2011/11/28
|
TORRENT PHARMS LTD |
| 203417 |
003 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2013/01/17
|
AUROBINDO PHARMA LTD |
| 201964 |
003 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2013/11/08
|
HERITAGE |
| 091200 |
003 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2013/12/13
|
SUN PHARM INDS LTD |
| 203032 |
003 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2015/05/21
|
ORBION PHARMS |
| 210847 |
003 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2018/10/26
|
YILING |
| 204800 |
003 |
ANDA |
FELODIPINE |
FELODIPINE |
TABLET, EXTENDED RELEASE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2019/04/29
|
YUNG SHIN PHARM |