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 |
|---|
| 2022/02/16 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/02/12 |
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:MORPHINE SULFATE 剂型/给药途径:SOLUTION;ORAL 规格:10MG/5ML 治疗等效代码:AA
| 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 |
|---|
| 022195 |
001 |
NDA |
MORPHINE SULFATE |
MORPHINE SULFATE |
SOLUTION;ORAL |
10MG/5ML |
Prescription |
Yes |
No |
AA |
2008/03/17
|
HIKMA |
| 203518 |
001 |
ANDA |
MORPHINE SULFATE |
MORPHINE SULFATE |
SOLUTION;ORAL |
10MG/5ML |
Prescription |
No |
No |
AA |
2015/05/12
|
TRIS PHARMA INC |
| 206308 |
001 |
ANDA |
MORPHINE SULFATE |
MORPHINE SULFATE |
SOLUTION;ORAL |
10MG/5ML |
Prescription |
No |
No |
AA |
2017/06/22
|
RHODES PHARMS |
| 211454 |
001 |
ANDA |
MORPHINE SULFATE |
MORPHINE SULFATE |
SOLUTION;ORAL |
10MG/5ML |
Prescription |
No |
No |
AA |
2021/02/12
|
WINDER LABS LLC |
| 206573 |
002 |
ANDA |
MORPHINE SULFATE |
MORPHINE SULFATE |
SOLUTION;ORAL |
10MG/5ML |
Discontinued |
No |
No |
AA |
2023/09/12
|
PHARM ASSOC |
活性成分:MORPHINE SULFATE 剂型/给药途径:SOLUTION;ORAL 规格:20MG/5ML 治疗等效代码:AA
| 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 |
|---|
| 022195 |
002 |
NDA |
MORPHINE SULFATE |
MORPHINE SULFATE |
SOLUTION;ORAL |
20MG/5ML |
Prescription |
Yes |
No |
AA |
2008/03/17
|
HIKMA |
| 203519 |
001 |
ANDA |
MORPHINE SULFATE |
MORPHINE SULFATE |
SOLUTION;ORAL |
20MG/5ML |
Discontinued |
No |
No |
AA |
2016/05/18
|
TRIS PHARMA INC |
| 206420 |
001 |
ANDA |
MORPHINE SULFATE |
MORPHINE SULFATE |
SOLUTION;ORAL |
20MG/5ML |
Prescription |
No |
No |
AA |
2016/07/12
|
RHODES PHARMS |
| 211454 |
002 |
ANDA |
MORPHINE SULFATE |
MORPHINE SULFATE |
SOLUTION;ORAL |
20MG/5ML |
Prescription |
No |
No |
AA |
2021/02/12
|
WINDER LABS LLC |
活性成分:MORPHINE SULFATE 剂型/给药途径:SOLUTION;ORAL 规格:100MG/5ML 治疗等效代码:AA
| 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 |
|---|
| 022195 |
003 |
NDA |
MORPHINE SULFATE |
MORPHINE SULFATE |
SOLUTION;ORAL |
100MG/5ML |
Prescription |
Yes |
Yes |
AA |
2010/01/25
|
HIKMA |
| 202348 |
001 |
ANDA |
MORPHINE SULFATE |
MORPHINE SULFATE |
SOLUTION;ORAL |
100MG/5ML |
Prescription |
No |
No |
AA |
2011/07/15
|
SPECGX LLC |
| 201574 |
001 |
ANDA |
MORPHINE SULFATE |
MORPHINE SULFATE |
SOLUTION;ORAL |
100MG/5ML |
Prescription |
No |
No |
AA |
2012/08/06
|
PADAGIS US |
| 203518 |
002 |
ANDA |
MORPHINE SULFATE |
MORPHINE SULFATE |
SOLUTION;ORAL |
100MG/5ML |
Prescription |
No |
No |
AA |
2015/05/12
|
TRIS PHARMA INC |
| 206573 |
001 |
ANDA |
MORPHINE SULFATE |
MORPHINE SULFATE |
SOLUTION;ORAL |
100MG/5ML |
Discontinued |
No |
No |
AA |
2016/11/14
|
PHARM ASSOC |
| 206308 |
002 |
ANDA |
MORPHINE SULFATE |
MORPHINE SULFATE |
SOLUTION;ORAL |
100MG/5ML |
Prescription |
No |
No |
AA |
2017/06/22
|
RHODES PHARMS |
| 208809 |
001 |
ANDA |
MORPHINE SULFATE |
MORPHINE SULFATE |
SOLUTION;ORAL |
100MG/5ML |
Discontinued |
No |
No |
AA |
2017/07/06
|
HIKMA |
| 211454 |
003 |
ANDA |
MORPHINE SULFATE |
MORPHINE SULFATE |
SOLUTION;ORAL |
100MG/5ML |
Prescription |
No |
No |
AA |
2021/02/12
|
WINDER LABS LLC |