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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 2017/05/05 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 2020/03/27 |
SUPPL-3（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2019/09/25 |
SUPPL-1（补充） |
Approval |
Labeling-Package Insert |
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:VERAPAMIL HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:180MG; 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 |
|---|
| 219252 |
002 |
ANDA |
VERAPAMIL HYDROCHLORIDE |
VERAPAMIL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
180MG |
Prescription |
No |
No |
AB |
--
|
ZYDUS LIFESCIENCES |
| 090700 |
002 |
ANDA |
VERAPAMIL HYDROCHLORIDE |
VERAPAMIL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
180MG |
Prescription |
No |
Yes |
AB |
2011/08/03
|
GLENMARK PHARMS LTD |
| 090529 |
002 |
ANDA |
VERAPAMIL HYDROCHLORIDE |
VERAPAMIL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
180MG |
Discontinued |
No |
No |
AB |
2011/12/30
|
SUN PHARM INDS INC |
| 206173 |
001 |
ANDA |
VERAPAMIL HYDROCHLORIDE |
VERAPAMIL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
180MG |
Prescription |
No |
No |
AB |
2017/05/05
|
CADILA PHARMS LTD |
>>>活性成分:VERAPAMIL HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:240MG; 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 |
|---|
| 219252 |
003 |
ANDA |
VERAPAMIL HYDROCHLORIDE |
VERAPAMIL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
240MG |
Prescription |
No |
No |
AB |
--
|
ZYDUS LIFESCIENCES |
| 075072 |
003 |
ANDA |
VERAPAMIL HYDROCHLORIDE |
VERAPAMIL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
240MG |
Prescription |
No |
No |
AB |
1999/05/25
|
STRIDES PHARMA INTL |
| 078906 |
001 |
ANDA |
VERAPAMIL HYDROCHLORIDE |
VERAPAMIL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
240MG |
Prescription |
No |
Yes |
AB |
2009/09/17
|
GLENMARK PHARMS LTD |
| 090529 |
003 |
ANDA |
VERAPAMIL HYDROCHLORIDE |
VERAPAMIL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
240MG |
Discontinued |
No |
No |
AB |
2011/12/30
|
SUN PHARM INDS INC |
| 206173 |
002 |
ANDA |
VERAPAMIL HYDROCHLORIDE |
VERAPAMIL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
240MG |
Prescription |
No |
No |
AB |
2017/05/05
|
CADILA PHARMS LTD |
>>>活性成分:VERAPAMIL HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:120MG; 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 |
|---|
| 219252 |
001 |
ANDA |
VERAPAMIL HYDROCHLORIDE |
VERAPAMIL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB |
--
|
ZYDUS LIFESCIENCES |
| 075072 |
001 |
ANDA |
VERAPAMIL HYDROCHLORIDE |
VERAPAMIL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB |
1999/05/25
|
STRIDES PHARMA INTL |
| 090700 |
001 |
ANDA |
VERAPAMIL HYDROCHLORIDE |
VERAPAMIL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
120MG |
Prescription |
No |
Yes |
AB |
2011/08/03
|
GLENMARK PHARMS LTD |
| 090529 |
001 |
ANDA |
VERAPAMIL HYDROCHLORIDE |
VERAPAMIL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
120MG |
Discontinued |
No |
No |
AB |
2011/12/30
|
SUN PHARM INDS INC |
| 206173 |
003 |
ANDA |
VERAPAMIL HYDROCHLORIDE |
VERAPAMIL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
120MG |
Prescription |
No |
No |
AB |
2022/11/14
|
CADILA PHARMS LTD |