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 |
|---|
| 2018/11/19 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/11/19 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/01/07 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/04/15 |
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:RAMIPRIL 剂型/给药途径:CAPSULE;ORAL 规格:1.25MG 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 |
|---|
| 019901 |
001 |
NDA |
ALTACE |
RAMIPRIL |
CAPSULE;ORAL |
1.25MG |
Prescription |
Yes |
No |
AB |
1991/01/28
|
KING PHARMS LLC |
| 076549 |
001 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
1.25MG |
Prescription |
No |
No |
AB |
2005/10/24
|
WATSON LABS |
| 077626 |
001 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
1.25MG |
Prescription |
No |
No |
AB |
2008/06/09
|
LUPIN |
| 077900 |
001 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
1.25MG |
Prescription |
No |
No |
AB |
2008/06/18
|
HIKMA |
| 078191 |
001 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
1.25MG |
Prescription |
No |
No |
AB |
2008/06/18
|
DR REDDYS LABS LTD |
| 078745 |
001 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
1.25MG |
Prescription |
No |
No |
AB |
2008/06/18
|
CHARTWELL MOLECULAR |
| 079116 |
001 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
1.25MG |
Prescription |
No |
No |
AB |
2008/06/20
|
COREPHARMA |
| 078832 |
001 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
1.25MG |
Prescription |
No |
No |
AB |
2008/09/02
|
ZYDUS PHARMS USA |
| 091604 |
001 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
1.25MG |
Prescription |
No |
No |
AB |
2011/06/08
|
AUROBINDO PHARMA LTD |
| 202392 |
001 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
1.25MG |
Discontinued |
No |
No |
AB |
2014/04/15
|
ACCORD HLTHCARE |
活性成分:RAMIPRIL 剂型/给药途径:CAPSULE;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 |
|---|
| 019901 |
002 |
NDA |
ALTACE |
RAMIPRIL |
CAPSULE;ORAL |
2.5MG |
Prescription |
Yes |
No |
AB |
1991/01/28
|
KING PHARMS LLC |
| 076549 |
002 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2005/10/24
|
WATSON LABS |
| 077626 |
002 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2008/06/09
|
LUPIN |
| 077900 |
002 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2008/06/18
|
HIKMA |
| 078191 |
002 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2008/06/18
|
DR REDDYS LABS LTD |
| 078745 |
002 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2008/06/18
|
CHARTWELL MOLECULAR |
| 079116 |
002 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2008/06/20
|
COREPHARMA |
| 078832 |
002 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2008/09/02
|
ZYDUS PHARMS USA |
| 091604 |
002 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
2.5MG |
Prescription |
No |
No |
AB |
2011/06/08
|
AUROBINDO PHARMA LTD |
| 202392 |
002 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
2.5MG |
Discontinued |
No |
No |
AB |
2014/04/15
|
ACCORD HLTHCARE |
活性成分:RAMIPRIL 剂型/给药途径:CAPSULE;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 |
|---|
| 019901 |
003 |
NDA |
ALTACE |
RAMIPRIL |
CAPSULE;ORAL |
5MG |
Prescription |
Yes |
No |
AB |
1991/01/28
|
KING PHARMS LLC |
| 077626 |
003 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
5MG |
Prescription |
No |
No |
AB |
2008/06/09
|
LUPIN |
| 077900 |
003 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
5MG |
Prescription |
No |
No |
AB |
2008/06/18
|
HIKMA |
| 078191 |
003 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
5MG |
Prescription |
No |
No |
AB |
2008/06/18
|
DR REDDYS LABS LTD |
| 078745 |
003 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
5MG |
Prescription |
No |
No |
AB |
2008/06/18
|
CHARTWELL MOLECULAR |
| 079116 |
003 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
5MG |
Prescription |
No |
No |
AB |
2008/06/20
|
COREPHARMA |
| 078832 |
003 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
5MG |
Prescription |
No |
No |
AB |
2008/09/02
|
ZYDUS PHARMS USA |
| 091604 |
003 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
5MG |
Prescription |
No |
No |
AB |
2011/06/08
|
AUROBINDO PHARMA LTD |
| 202392 |
003 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
5MG |
Discontinued |
No |
No |
AB |
2014/04/15
|
ACCORD HLTHCARE |
活性成分:RAMIPRIL 剂型/给药途径:CAPSULE;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 |
|---|
| 019901 |
004 |
NDA |
ALTACE |
RAMIPRIL |
CAPSULE;ORAL |
10MG |
Prescription |
Yes |
Yes |
AB |
1991/01/28
|
KING PHARMS LLC |
| 076549 |
004 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2005/10/24
|
WATSON LABS |
| 077626 |
004 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2008/06/09
|
LUPIN |
| 077900 |
004 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2008/06/18
|
HIKMA |
| 078191 |
004 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2008/06/18
|
DR REDDYS LABS LTD |
| 078745 |
004 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2008/06/18
|
CHARTWELL MOLECULAR |
| 079116 |
004 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2008/06/20
|
COREPHARMA |
| 078832 |
004 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2008/09/02
|
ZYDUS PHARMS USA |
| 091604 |
004 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
10MG |
Prescription |
No |
No |
AB |
2011/06/08
|
AUROBINDO PHARMA LTD |
| 202392 |
004 |
ANDA |
RAMIPRIL |
RAMIPRIL |
CAPSULE;ORAL |
10MG |
Discontinued |
No |
No |
AB |
2014/04/15
|
ACCORD HLTHCARE |