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 |
|---|
| 2023/04/26 |
SUPPL-7（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/03/02 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/07/18 |
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:SPIRONOLACTONE 剂型/给药途径:TABLET;ORAL 规格: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 |
|---|
| 012151 |
009 |
NDA |
ALDACTONE |
SPIRONOLACTONE |
TABLET;ORAL |
25MG |
Prescription |
Yes |
No |
AB |
1983/12/30
|
PFIZER |
| 089424 |
001 |
ANDA |
SPIRONOLACTONE |
SPIRONOLACTONE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
1986/07/23
|
SUN PHARM INDUSTRIES |
| 040424 |
001 |
ANDA |
SPIRONOLACTONE |
SPIRONOLACTONE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2001/08/20
|
MYLAN |
| 040750 |
001 |
ANDA |
SPIRONOLACTONE |
SPIRONOLACTONE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2006/08/29
|
OXFORD PHARMS |
| 091426 |
001 |
ANDA |
SPIRONOLACTONE |
SPIRONOLACTONE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2010/07/02
|
AMNEAL PHARMS |
| 202187 |
001 |
ANDA |
SPIRONOLACTONE |
SPIRONOLACTONE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2014/03/06
|
AUROBINDO PHARMA |
| 203253 |
001 |
ANDA |
SPIRONOLACTONE |
SPIRONOLACTONE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2014/04/23
|
JUBILANT GENERICS |
| 203512 |
001 |
ANDA |
SPIRONOLACTONE |
SPIRONOLACTONE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2016/09/19
|
ACCORD HLTHCARE |
| 205936 |
001 |
ANDA |
SPIRONOLACTONE |
SPIRONOLACTONE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2018/07/18
|
ZYDUS PHARMS |
活性成分:SPIRONOLACTONE 剂型/给药途径:TABLET;ORAL 规格:50MG 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 |
|---|
| 012151 |
008 |
NDA |
ALDACTONE |
SPIRONOLACTONE |
TABLET;ORAL |
50MG |
Prescription |
Yes |
No |
AB |
1982/12/30
|
PFIZER |
| 089424 |
002 |
ANDA |
SPIRONOLACTONE |
SPIRONOLACTONE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
1999/08/11
|
SUN PHARM INDUSTRIES |
| 040424 |
002 |
ANDA |
SPIRONOLACTONE |
SPIRONOLACTONE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2001/08/20
|
MYLAN |
| 040750 |
002 |
ANDA |
SPIRONOLACTONE |
SPIRONOLACTONE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2006/08/29
|
OXFORD PHARMS |
| 091426 |
002 |
ANDA |
SPIRONOLACTONE |
SPIRONOLACTONE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2010/07/02
|
AMNEAL PHARMS |
| 202187 |
002 |
ANDA |
SPIRONOLACTONE |
SPIRONOLACTONE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2014/03/06
|
AUROBINDO PHARMA |
| 203253 |
002 |
ANDA |
SPIRONOLACTONE |
SPIRONOLACTONE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2014/04/23
|
JUBILANT GENERICS |
| 203512 |
002 |
ANDA |
SPIRONOLACTONE |
SPIRONOLACTONE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2016/09/19
|
ACCORD HLTHCARE |
| 205936 |
002 |
ANDA |
SPIRONOLACTONE |
SPIRONOLACTONE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2018/07/18
|
ZYDUS PHARMS |
活性成分:SPIRONOLACTONE 剂型/给药途径:TABLET;ORAL 规格:100MG 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 |
|---|
| 012151 |
010 |
NDA |
ALDACTONE |
SPIRONOLACTONE |
TABLET;ORAL |
100MG |
Prescription |
Yes |
Yes |
AB |
1983/12/30
|
PFIZER |
| 089424 |
003 |
ANDA |
SPIRONOLACTONE |
SPIRONOLACTONE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
1999/08/11
|
SUN PHARM INDUSTRIES |
| 040424 |
003 |
ANDA |
SPIRONOLACTONE |
SPIRONOLACTONE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2001/08/20
|
MYLAN |
| 040750 |
003 |
ANDA |
SPIRONOLACTONE |
SPIRONOLACTONE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2006/08/29
|
OXFORD PHARMS |
| 091426 |
003 |
ANDA |
SPIRONOLACTONE |
SPIRONOLACTONE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2010/07/02
|
AMNEAL PHARMS |
| 202187 |
003 |
ANDA |
SPIRONOLACTONE |
SPIRONOLACTONE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2014/03/06
|
AUROBINDO PHARMA |
| 203253 |
003 |
ANDA |
SPIRONOLACTONE |
SPIRONOLACTONE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2014/04/23
|
JUBILANT GENERICS |
| 203512 |
003 |
ANDA |
SPIRONOLACTONE |
SPIRONOLACTONE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2016/09/19
|
ACCORD HLTHCARE |
| 205936 |
003 |
ANDA |
SPIRONOLACTONE |
SPIRONOLACTONE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2018/07/18
|
ZYDUS PHARMS |