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 |
|---|
| 2022/07/14 |
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:METHOCARBAMOL 剂型/给药途径:SOLUTION;IM-IV 规格:1GM/10ML (100MG/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 |
|---|
| 011790 |
001 |
NDA |
ROBAXIN |
METHOCARBAMOL |
SOLUTION;IM-IV |
1GM/10ML (100MG/ML) |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
HIKMA |
| 204404 |
001 |
ANDA |
METHOCARBAMOL |
METHOCARBAMOL |
SOLUTION;IM-IV |
1GM/10ML (100MG/ML) |
Discontinued |
No |
No |
AP |
2014/12/05
|
MYLAN INSTITUTIONAL |
| 206128 |
001 |
ANDA |
METHOCARBAMOL |
METHOCARBAMOL |
SOLUTION;IM-IV |
1GM/10ML (100MG/ML) |
Prescription |
No |
No |
AP |
2016/05/27
|
EUGIA PHARMA |
| 205354 |
001 |
ANDA |
METHOCARBAMOL |
METHOCARBAMOL |
SOLUTION;IM-IV |
1GM/10ML (100MG/ML) |
Prescription |
No |
No |
AP |
2016/10/27
|
MONTEREY PHARMS LLC |
| 208116 |
001 |
ANDA |
METHOCARBAMOL |
METHOCARBAMOL |
SOLUTION;IM-IV |
1GM/10ML (100MG/ML) |
Prescription |
No |
No |
AP |
2017/01/19
|
SLATE RUN PHARMA |
| 207496 |
001 |
ANDA |
METHOCARBAMOL |
METHOCARBAMOL |
SOLUTION;IM-IV |
1GM/10ML (100MG/ML) |
Prescription |
No |
No |
AP |
2017/06/22
|
AM REGENT |
| 205404 |
001 |
ANDA |
METHOCARBAMOL |
METHOCARBAMOL |
SOLUTION;IM-IV |
1GM/10ML (100MG/ML) |
Prescription |
No |
No |
AP |
2017/07/18
|
SAGENT PHARMS INC |
| 207522 |
001 |
ANDA |
METHOCARBAMOL |
METHOCARBAMOL |
SOLUTION;IM-IV |
1GM/10ML (100MG/ML) |
Prescription |
No |
No |
AP |
2017/07/31
|
SOMERSET THERAPS LLC |
| 206071 |
001 |
ANDA |
METHOCARBAMOL |
METHOCARBAMOL |
SOLUTION;IM-IV |
1GM/10ML (100MG/ML) |
Prescription |
No |
No |
AP |
2017/11/24
|
NAVINTA LLC |
| 209331 |
001 |
ANDA |
METHOCARBAMOL |
METHOCARBAMOL |
SOLUTION;IM-IV |
1GM/10ML (100MG/ML) |
Prescription |
No |
No |
AP |
2018/04/17
|
FRESENIUS KABI USA |
| 211504 |
001 |
ANDA |
METHOCARBAMOL |
METHOCARBAMOL |
SOLUTION;IM-IV |
1GM/10ML (100MG/ML) |
Prescription |
No |
No |
AP |
2018/10/26
|
GLAND PHARMA LTD |
| 215065 |
001 |
ANDA |
METHOCARBAMOL |
METHOCARBAMOL |
SOLUTION;IM-IV |
1GM/10ML (100MG/ML) |
Discontinued |
No |
No |
AP |
2022/07/14
|
BAXTER HLTHCARE CORP |