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 |
|---|
| 2023/02/23 |
SUPPL-14（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2003/07/09 |
SUPPL-3（补充） |
Approval |
Labeling |
|
|
|
| 2001/04/03 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/06/23 |
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:MIDAZOLAM HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 5MG BASE/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 |
|---|
| 075293 |
002 |
ANDA |
MIDAZOLAM HYDROCHLORIDE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 5MG BASE/ML |
Prescription |
No |
Yes |
AP |
2000/06/20
|
HOSPIRA |
| 075324 |
002 |
ANDA |
MIDAZOLAM HYDROCHLORIDE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 5MG BASE/ML |
Prescription |
No |
No |
AP |
2000/06/20
|
HIKMA |
| 075421 |
001 |
ANDA |
MIDAZOLAM HYDROCHLORIDE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 5MG BASE/ML |
Prescription |
No |
No |
AP |
2000/06/20
|
HIKMA |
| 075154 |
001 |
ANDA |
MIDAZOLAM HYDROCHLORIDE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 5MG BASE/ML |
Prescription |
No |
No |
AP |
2000/06/20
|
FRESENIUS KABI USA |
| 075243 |
002 |
ANDA |
MIDAZOLAM HYDROCHLORIDE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 5MG BASE/ML |
Prescription |
No |
No |
AP |
2000/06/20
|
HIKMA |
| 075247 |
001 |
ANDA |
MIDAZOLAM HYDROCHLORIDE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 5MG BASE/ML |
Prescription |
No |
No |
AP |
2000/06/23
|
HIKMA |
| 075494 |
002 |
ANDA |
MIDAZOLAM HYDROCHLORIDE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 5MG BASE/ML |
Prescription |
No |
No |
AP |
2000/06/30
|
EPIC PHARMA LLC |
| 075857 |
002 |
ANDA |
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 5MG BASE/ML |
Prescription |
No |
Yes |
AP |
2002/07/22
|
HOSPIRA |
| 090315 |
002 |
ANDA |
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 5MG BASE/ML |
Prescription |
No |
No |
AP |
2010/11/29
|
STERISCIENCE |
| 090316 |
002 |
ANDA |
MIDOZALAM HYDROCHLORIDE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 5MG BASE/ML |
Prescription |
No |
No |
AP |
2011/05/04
|
STERISCIENCE |
| 090850 |
001 |
ANDA |
MIDAZOLAM HYDROCHLORIDE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 5MG BASE/ML |
Prescription |
No |
No |
AP |
2012/01/25
|
GLAND PHARMA LTD |
| 203460 |
002 |
ANDA |
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 5MG BASE/ML |
Prescription |
No |
No |
AP |
2014/08/22
|
FRESENIUS KABI USA |
| 212847 |
002 |
ANDA |
MIDAZOLAM HYDROCHLORIDE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 5MG BASE/ML |
Prescription |
No |
No |
AP |
2020/12/11
|
HIKMA |
| 217504 |
002 |
ANDA |
MIDAZOLAM HYDROCHLORIDE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 5MG BASE/ML |
Prescription |
No |
No |
AP |
2023/08/21
|
MICRO LABS |
活性成分:MIDAZOLAM HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 1MG BASE/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 |
|---|
| 075293 |
001 |
ANDA |
MIDAZOLAM HYDROCHLORIDE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
Yes |
AP |
2000/06/20
|
HOSPIRA |
| 075324 |
001 |
ANDA |
MIDAZOLAM HYDROCHLORIDE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2000/06/20
|
HIKMA |
| 075421 |
002 |
ANDA |
MIDAZOLAM HYDROCHLORIDE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2000/06/20
|
HIKMA |
| 075154 |
002 |
ANDA |
MIDAZOLAM HYDROCHLORIDE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2000/06/20
|
FRESENIUS KABI USA |
| 075243 |
001 |
ANDA |
MIDAZOLAM HYDROCHLORIDE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2000/06/20
|
HIKMA |
| 075247 |
002 |
ANDA |
MIDAZOLAM HYDROCHLORIDE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2000/06/23
|
HIKMA |
| 075494 |
001 |
ANDA |
MIDAZOLAM HYDROCHLORIDE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2000/06/30
|
EPIC PHARMA LLC |
| 075857 |
001 |
ANDA |
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
Yes |
AP |
2002/07/22
|
HOSPIRA |
| 090315 |
001 |
ANDA |
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2010/11/29
|
STERISCIENCE |
| 090316 |
001 |
ANDA |
MIDOZALAM HYDROCHLORIDE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2011/05/04
|
STERISCIENCE |
| 090696 |
001 |
ANDA |
MIDAZOLAM HYDROCHLORIDE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2012/02/29
|
GLAND PHARMA LTD |
| 203460 |
001 |
ANDA |
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2014/08/22
|
FRESENIUS KABI USA |
| 212847 |
001 |
ANDA |
MIDAZOLAM HYDROCHLORIDE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2020/12/11
|
HIKMA |
| 217504 |
001 |
ANDA |
MIDAZOLAM HYDROCHLORIDE |
MIDAZOLAM HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2023/08/21
|
MICRO LABS |
