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 |
|---|
| 2019/11/22 |
SUPPL-8（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/01/04 |
SUPPL-7（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/01/04 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/10/26 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/09/27 |
SUPPL-3（补充） |
Approval |
Labeling |
|
|
|
| 2011/12/12 |
SUPPL-2（补充） |
Approval |
Labeling |
|
|
|
| 2011/08/31 |
SUPPL-1（补充） |
Approval |
Labeling |
|
|
|
| 2011/07/05 |
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:AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 5MG BASE;40MG 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 |
|---|
| 020364 |
007 |
NDA |
LOTREL |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 5MG BASE;40MG |
Prescription |
Yes |
No |
AB |
2006/04/11
|
SANDOZ |
| 078466 |
005 |
ANDA |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 5MG BASE;40MG |
Prescription |
No |
No |
AB |
2011/07/05
|
LUPIN PHARMS |
| 090149 |
001 |
ANDA |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 5MG BASE;40MG |
Prescription |
No |
No |
AB |
2011/07/05
|
DR REDDYS LABS INC |
| 090364 |
001 |
ANDA |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 5MG BASE;40MG |
Prescription |
No |
No |
AB |
2011/07/05
|
WATSON LABS INC |
| 202239 |
004 |
ANDA |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 5MG BASE;40MG |
Prescription |
No |
No |
AB |
2012/09/05
|
AUROBINDO PHARMA LTD |
| 091431 |
004 |
ANDA |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 5MG BASE;40MG |
Prescription |
No |
No |
AB |
2013/12/30
|
APOTEX |
活性成分:AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 10MG BASE;40MG 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 |
|---|
| 020364 |
006 |
NDA |
LOTREL |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE;40MG |
Prescription |
Yes |
Yes |
AB |
2006/04/11
|
SANDOZ |
| 078466 |
006 |
ANDA |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE;40MG |
Prescription |
No |
No |
AB |
2011/07/05
|
LUPIN PHARMS |
| 090149 |
002 |
ANDA |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE;40MG |
Prescription |
No |
No |
AB |
2011/07/05
|
DR REDDYS LABS INC |
| 090364 |
002 |
ANDA |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE;40MG |
Prescription |
No |
No |
AB |
2011/07/05
|
WATSON LABS INC |
| 202239 |
006 |
ANDA |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE;40MG |
Prescription |
No |
No |
AB |
2012/09/05
|
AUROBINDO PHARMA LTD |
| 091431 |
006 |
ANDA |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE;40MG |
Prescription |
No |
No |
AB |
2013/12/30
|
APOTEX |