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 |
|---|
| 1962/08/13 |
ORIG-1（原始申请） |
Approval |
Type 1 - New Molecular Entity |
STANDARD
|
|
|
>>>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 |
|---|
| 2024/06/21 |
SUPPL-62（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2018/03/06 |
SUPPL-57（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2016/05/09 |
SUPPL-58（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2014/09/29 |
SUPPL-56（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2014/01/27 |
SUPPL-55（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2008/10/31 |
SUPPL-53（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2006/11/24 |
SUPPL-46（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2002/08/30 |
SUPPL-36（补充） |
Approval |
Manufacturing (CMC)-Formulation |
STANDARD
|
|
|
| 2002/06/20 |
SUPPL-44（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2002/06/03 |
SUPPL-45（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 2002/04/16 |
SUPPL-43（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2001/09/26 |
SUPPL-41（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2001/01/31 |
SUPPL-40（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2000/05/04 |
SUPPL-37（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1999/04/13 |
SUPPL-34（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1999/04/13 |
SUPPL-32（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1998/09/18 |
SUPPL-35（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1998/03/26 |
SUPPL-33（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1997/07/07 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1997/03/20 |
SUPPL-31（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1995/06/28 |
SUPPL-29（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1995/03/27 |
SUPPL-28（补充） |
Approval |
Manufacturing (CMC)-Packaging |
STANDARD
|
|
|
| 1995/01/05 |
SUPPL-27（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1992/07/27 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC)-Packaging |
STANDARD
|
|
|
| 1989/02/28 |
SUPPL-24（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1987/02/26 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/12/31 |
SUPPL-19（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1985/12/04 |
SUPPL-17（补充） |
Approval |
Labeling |
|
|
|
| 1985/05/31 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 1984/03/27 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC)-Packaging |
STANDARD
|
|
|
| 1984/03/27 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/01/16 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1981/01/16 |
SUPPL-11（补充） |
Approval |
Labeling |
|
|
|
| 1980/04/15 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1980/02/13 |
SUPPL-9（补充） |
Approval |
Labeling |
|
|
|
| 1979/02/26 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC)-Expiration Date |
STANDARD
|
|
|
| 1977/04/04 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC)-Formulation |
STANDARD
|
|
|
与本品相关的专利信息（来自FDA橙皮书Orange Book）
与本品治疗等效的药品
>>>活性成分:METAXALONE; 剂型/给药途径:TABLET;ORAL; 规格:800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 治疗等效代码:AB<<<
| 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 |
|---|
| 013217 |
003 |
NDA |
SKELAXIN |
METAXALONE |
TABLET;ORAL |
800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Discontinued |
Yes |
No |
AB |
2002/08/30
|
KING PHARMS |
