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 |
|---|
| 2024/08/05 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
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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:REGADENOSON 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:0.4MG/5ML (0.08MG/ML) 治疗等效代码:AP
| 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 |
|---|
| 022161 |
001 |
NDA |
LEXISCAN |
REGADENOSON |
SOLUTION;INTRAVENOUS |
0.4MG/5ML (0.08MG/ML) |
Prescription |
Yes |
Yes |
AP |
2008/04/10
|
ASTELLAS |
| 207604 |
001 |
ANDA |
REGADENOSON |
REGADENOSON |
SOLUTION;INTRAVENOUS |
0.4MG/5ML (0.08MG/ML) |
Prescription |
No |
No |
AP |
2022/04/11
|
APOTEX |
| 212806 |
001 |
ANDA |
REGADENOSON |
REGADENOSON |
SOLUTION;INTRAVENOUS |
0.4MG/5ML (0.08MG/ML) |
Prescription |
No |
No |
AP |
2022/04/11
|
MEITHEAL |
| 213210 |
001 |
ANDA |
REGADENOSON |
REGADENOSON |
SOLUTION;INTRAVENOUS |
0.4MG/5ML (0.08MG/ML) |
Prescription |
No |
No |
AP |
2022/04/11
|
DR REDDYS |
| 213236 |
001 |
ANDA |
REGADENOSON |
REGADENOSON |
SOLUTION;INTRAVENOUS |
0.4MG/5ML (0.08MG/ML) |
Prescription |
No |
No |
AP |
2022/04/11
|
ACCORD HLTHCARE |
| 214252 |
001 |
ANDA |
REGADENOSON |
REGADENOSON |
SOLUTION;INTRAVENOUS |
0.4MG/5ML (0.08MG/ML) |
Prescription |
No |
No |
AP |
2022/05/23
|
IMS LTD |
| 207320 |
001 |
ANDA |
REGADENOSON |
REGADENOSON |
SOLUTION;INTRAVENOUS |
0.4MG/5ML (0.08MG/ML) |
Prescription |
No |
No |
AP |
2022/07/12
|
GLAND PHARMA LTD |
| 214349 |
001 |
ANDA |
REGADENOSON |
REGADENOSON |
SOLUTION;INTRAVENOUS |
0.4MG/5ML (0.08MG/ML) |
Prescription |
No |
No |
AP |
2022/08/31
|
HOSPIRA |
| 216437 |
001 |
ANDA |
REGADENOSON |
REGADENOSON |
SOLUTION;INTRAVENOUS |
0.4MG/5ML (0.08MG/ML) |
Prescription |
No |
No |
AP |
2022/10/26
|
EUGIA PHARMA |
| 215827 |
001 |
ANDA |
REGADENOSON |
REGADENOSON |
SOLUTION;INTRAVENOUS |
0.4MG/5ML (0.08MG/ML) |
Prescription |
No |
No |
AP |
2023/02/02
|
HIKMA |
| 213856 |
001 |
ANDA |
REGADENOSON |
REGADENOSON |
SOLUTION;INTRAVENOUS |
0.4MG/5ML (0.08MG/ML) |
Prescription |
No |
No |
AP |
2023/04/04
|
MYLAN |
| 217455 |
001 |
ANDA |
REGADENOSON |
REGADENOSON |
SOLUTION;INTRAVENOUS |
0.4MG/5ML (0.08MG/ML) |
Prescription |
No |
No |
AP |
2023/05/23
|
BAXTER HLTHCARE CORP |
| 215955 |
001 |
ANDA |
REGADENOSON |
REGADENOSON |
SOLUTION;INTRAVENOUS |
0.4MG/5ML (0.08MG/ML) |
Prescription |
No |
No |
AP |
2024/08/05
|
GE HEALTHCARE |
| 218054 |
001 |
ANDA |
REGADENOSON |
REGADENOSON |
SOLUTION;INTRAVENOUS |
0.4MG/5ML (0.08MG/ML) |
Prescription |
No |
No |
AP |
2024/08/22
|
INDIES PHARMA |