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 |
|---|
| 2015/08/25 |
SUPPL-4（补充） |
Approval |
Labeling |
|
|
|
| 2007/02/07 |
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:SOTALOL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:80MG 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 |
|---|
| 019865 |
001 |
NDA |
BETAPACE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
80MG |
Prescription |
Yes |
No |
AB |
1992/10/30
|
LEGACY PHARMA |
| 021151 |
001 |
NDA |
BETAPACE AF |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
80MG |
Prescription |
Yes |
No |
AB |
2000/02/22
|
LEGACY PHARMA |
| 075429 |
001 |
ANDA |
SOTALOL HYDROCHLORIDE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
80MG |
Prescription |
No |
No |
AB |
2000/05/01
|
TEVA |
| 075500 |
001 |
ANDA |
SORINE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
80MG |
Prescription |
No |
No |
AB |
2001/04/27
|
AIPING PHARM INC |
| 076140 |
001 |
ANDA |
SOTALOL HYDROCHLORIDE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
80MG |
Prescription |
No |
No |
AB |
2002/09/26
|
APOTEX |
| 076214 |
001 |
ANDA |
SOTALOL HYDROCHLORIDE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
80MG |
Prescription |
No |
No |
AB |
2003/08/27
|
APOTEX |
| 075563 |
001 |
ANDA |
SOTALOL HYDROCHLORIDE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
80MG |
Prescription |
No |
No |
AB |
2003/11/07
|
OXFORD PHARMS |
| 077070 |
001 |
ANDA |
SOTALOL HYDROCHLORIDE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
80MG |
Prescription |
No |
No |
AB |
2005/11/04
|
EPIC PHARMA LLC |
| 077616 |
001 |
ANDA |
SOTALOL HYDROCHLORIDE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
80MG |
Prescription |
No |
No |
AB |
2007/02/07
|
AUROBINDO PHARMA USA |
| 207428 |
001 |
ANDA |
SOTALOL HYDROCHLORIDE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
80MG |
Prescription |
No |
No |
AB |
2016/10/21
|
BEXIMCO PHARMS USA |
| 207429 |
001 |
ANDA |
SOTALOL HYDROCHLORIDE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
80MG |
Prescription |
No |
No |
AB |
2018/11/02
|
BEXIMCO PHARMS USA |
活性成分:SOTALOL HYDROCHLORIDE 剂型/给药途径:TABLET;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 |
|---|
| 019865 |
005 |
NDA |
BETAPACE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
120MG |
Prescription |
Yes |
No |
AB |
1994/04/20
|
LEGACY PHARMA |
| 021151 |
002 |
NDA |
BETAPACE AF |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
120MG |
Prescription |
Yes |
No |
AB |
2000/02/22
|
LEGACY PHARMA |
| 075429 |
002 |
ANDA |
SOTALOL HYDROCHLORIDE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
120MG |
Prescription |
No |
No |
AB |
2000/05/01
|
TEVA |
| 075500 |
004 |
ANDA |
SORINE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
120MG |
Prescription |
No |
No |
AB |
2001/04/27
|
AIPING PHARM INC |
| 076140 |
002 |
ANDA |
SOTALOL HYDROCHLORIDE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
120MG |
Prescription |
No |
No |
AB |
2002/09/26
|
APOTEX |
| 076214 |
002 |
ANDA |
SOTALOL HYDROCHLORIDE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
120MG |
Prescription |
No |
No |
AB |
2003/08/27
|
APOTEX |
| 075563 |
002 |
ANDA |
SOTALOL HYDROCHLORIDE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
120MG |
Prescription |
No |
No |
AB |
2003/11/07
|
OXFORD PHARMS |
| 077070 |
002 |
ANDA |
SOTALOL HYDROCHLORIDE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
120MG |
Prescription |
No |
No |
AB |
2005/11/04
|
EPIC PHARMA LLC |
| 077616 |
002 |
ANDA |
SOTALOL HYDROCHLORIDE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
120MG |
Prescription |
No |
No |
AB |
2007/02/07
|
AUROBINDO PHARMA USA |
| 207428 |
002 |
ANDA |
SOTALOL HYDROCHLORIDE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
120MG |
Prescription |
No |
No |
AB |
2016/10/21
|
BEXIMCO PHARMS USA |
| 207429 |
002 |
ANDA |
SOTALOL HYDROCHLORIDE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
120MG |
Prescription |
No |
No |
AB |
2018/11/02
|
BEXIMCO PHARMS USA |
活性成分:SOTALOL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:160MG 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 |
|---|
| 019865 |
002 |
NDA |
BETAPACE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
160MG |
Prescription |
Yes |
Yes |
AB |
1992/10/30
|
LEGACY PHARMA |
| 021151 |
003 |
NDA |
BETAPACE AF |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
160MG |
Prescription |
Yes |
Yes |
AB |
2000/02/22
|
LEGACY PHARMA |
| 075429 |
003 |
ANDA |
SOTALOL HYDROCHLORIDE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
160MG |
Prescription |
No |
No |
AB |
2000/05/01
|
TEVA |
| 075500 |
002 |
ANDA |
SORINE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
160MG |
Prescription |
No |
No |
AB |
2001/04/27
|
AIPING PHARM INC |
| 076140 |
003 |
ANDA |
SOTALOL HYDROCHLORIDE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
160MG |
Prescription |
No |
No |
AB |
2002/09/26
|
APOTEX |
| 076214 |
003 |
ANDA |
SOTALOL HYDROCHLORIDE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
160MG |
Prescription |
No |
No |
AB |
2003/08/27
|
APOTEX |
| 075563 |
003 |
ANDA |
SOTALOL HYDROCHLORIDE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
160MG |
Prescription |
No |
No |
AB |
2003/11/07
|
OXFORD PHARMS |
| 077070 |
003 |
ANDA |
SOTALOL HYDROCHLORIDE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
160MG |
Prescription |
No |
No |
AB |
2005/11/04
|
EPIC PHARMA LLC |
| 077616 |
003 |
ANDA |
SOTALOL HYDROCHLORIDE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
160MG |
Prescription |
No |
No |
AB |
2007/02/07
|
AUROBINDO PHARMA USA |
| 207428 |
003 |
ANDA |
SOTALOL HYDROCHLORIDE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
160MG |
Prescription |
No |
No |
AB |
2016/10/21
|
BEXIMCO PHARMS USA |
| 207429 |
003 |
ANDA |
SOTALOL HYDROCHLORIDE |
SOTALOL HYDROCHLORIDE |
TABLET;ORAL |
160MG |
Prescription |
No |
No |
AB |
2018/11/02
|
BEXIMCO PHARMS USA |