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 |
|---|
| 2009/03/23 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
>>>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 |
|---|
| 无 |
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:FLUMAZENIL; 剂型/给药途径:INJECTABLE;INJECTION; 规格:0.5MG/5ML (0.1MG/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 |
|---|
| 076256 |
002 |
ANDA |
FLUMAZENIL |
FLUMAZENIL |
INJECTABLE;INJECTION |
0.5MG/5ML (0.1MG/ML) |
Prescription |
No |
No |
AP |
2004/10/12
|
HIKMA |
| 076755 |
002 |
ANDA |
FLUMAZENIL |
FLUMAZENIL |
INJECTABLE;INJECTION |
0.5MG/5ML (0.1MG/ML) |
Prescription |
No |
No |
AP |
2004/10/12
|
BAXTER HLTHCARE CORP |
| 076787 |
002 |
ANDA |
FLUMAZENIL |
FLUMAZENIL |
INJECTABLE;INJECTION |
0.5MG/5ML (0.1MG/ML) |
Prescription |
No |
No |
AP |
2004/10/12
|
HIKMA |
| 076955 |
002 |
ANDA |
FLUMAZENIL |
FLUMAZENIL |
INJECTABLE;INJECTION |
0.5MG/5ML (0.1MG/ML) |
Prescription |
No |
No |
AP |
2004/10/12
|
FRESENIUS KABI USA |
| 077071 |
001 |
ANDA |
FLUMAZENIL |
FLUMAZENIL |
INJECTABLE;INJECTION |
0.5MG/5ML (0.1MG/ML) |
Prescription |
No |
No |
AP |
2005/05/03
|
SANDOZ |
| 078595 |
001 |
ANDA |
FLUMAZENIL |
FLUMAZENIL |
INJECTABLE;INJECTION |
0.5MG/5ML (0.1MG/ML) |
Prescription |
No |
No |
AP |
2008/05/13
|
RISING |
| 078527 |
001 |
ANDA |
FLUMAZENIL |
FLUMAZENIL |
INJECTABLE;INJECTION |
0.5MG/5ML (0.1MG/ML) |
Prescription |
No |
No |
AP |
2009/03/23
|
HIKMA FARMACEUTICA |
| 090584 |
001 |
ANDA |
FLUMAZENIL |
FLUMAZENIL |
INJECTABLE;INJECTION |
0.5MG/5ML (0.1MG/ML) |
Prescription |
No |
No |
AP |
2012/08/28
|
SAGENT PHARMS |
>>>活性成分:FLUMAZENIL; 剂型/给药途径:INJECTABLE;INJECTION; 规格:1MG/10ML (0.1MG/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 |
|---|
| 076256 |
001 |
ANDA |
FLUMAZENIL |
FLUMAZENIL |
INJECTABLE;INJECTION |
1MG/10ML (0.1MG/ML) |
Prescription |
No |
No |
AP |
2004/10/12
|
HIKMA |
| 076755 |
001 |
ANDA |
FLUMAZENIL |
FLUMAZENIL |
INJECTABLE;INJECTION |
1MG/10ML (0.1MG/ML) |
Prescription |
No |
No |
AP |
2004/10/12
|
BAXTER HLTHCARE CORP |
| 076787 |
001 |
ANDA |
FLUMAZENIL |
FLUMAZENIL |
INJECTABLE;INJECTION |
1MG/10ML (0.1MG/ML) |
Prescription |
No |
No |
AP |
2004/10/12
|
HIKMA |
| 076955 |
001 |
ANDA |
FLUMAZENIL |
FLUMAZENIL |
INJECTABLE;INJECTION |
1MG/10ML (0.1MG/ML) |
Prescription |
No |
No |
AP |
2004/10/12
|
FRESENIUS KABI USA |
| 077071 |
002 |
ANDA |
FLUMAZENIL |
FLUMAZENIL |
INJECTABLE;INJECTION |
1MG/10ML (0.1MG/ML) |
Prescription |
No |
No |
AP |
2005/05/03
|
SANDOZ |
| 078527 |
002 |
ANDA |
FLUMAZENIL |
FLUMAZENIL |
INJECTABLE;INJECTION |
1MG/10ML (0.1MG/ML) |
Prescription |
No |
Yes |
AP |
2009/03/23
|
HIKMA FARMACEUTICA |
| 090584 |
002 |
ANDA |
FLUMAZENIL |
FLUMAZENIL |
INJECTABLE;INJECTION |
1MG/10ML (0.1MG/ML) |
Prescription |
No |
No |
AP |
2012/08/28
|
SAGENT PHARMS |