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 |
|---|
| 1946/11/19 |
ORIG-1（原始申请） |
Approval |
|
UNKNOWN
|
|
|
>>>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 |
|---|
| 2025/05/29 |
SUPPL-80（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2013/05/21 |
SUPPL-79（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2012/06/25 |
SUPPL-78（补充） |
Approval |
Labeling-Package Insert |
UNKNOWN
|
|
|
| 2007/04/26 |
SUPPL-75（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2004/02/18 |
SUPPL-72（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2003/10/01 |
SUPPL-73（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2002/02/05 |
SUPPL-69（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2002/02/05 |
SUPPL-68（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2002/01/28 |
SUPPL-67（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/05/22 |
SUPPL-65（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 2001/04/03 |
SUPPL-66（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/04/14 |
SUPPL-64（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/12/09 |
SUPPL-63（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/04/22 |
SUPPL-62（补充） |
Approval |
Manufacturing (CMC)-Packaging |
|
|
|
| 1997/07/15 |
SUPPL-61（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1997/05/27 |
SUPPL-60（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1996/02/22 |
SUPPL-58（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1996/02/21 |
SUPPL-59（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/10/17 |
SUPPL-57（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1995/09/22 |
SUPPL-56（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1995/09/22 |
SUPPL-55（补充） |
Approval |
Manufacturing (CMC)-Packaging |
|
|
|
| 1995/03/22 |
SUPPL-50（补充） |
Approval |
Labeling |
|
|
|
| 1994/07/18 |
SUPPL-51（补充） |
Approval |
Manufacturing (CMC)-Formulation |
|
|
|
| 1994/07/07 |
SUPPL-54（补充） |
Approval |
Manufacturing (CMC)-Packaging |
|
|
|
| 1994/04/25 |
SUPPL-52（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1993/03/11 |
SUPPL-53（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1991/05/28 |
SUPPL-49（补充） |
Approval |
Labeling |
|
|
|
| 1990/09/06 |
SUPPL-48（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1989/10/20 |
SUPPL-47（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1989/10/20 |
SUPPL-46（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1989/10/20 |
SUPPL-44（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1989/10/20 |
SUPPL-43（补充） |
Approval |
Manufacturing (CMC)-Formulation |
|
|
|
| 1989/03/02 |
SUPPL-42（补充） |
Approval |
Manufacturing (CMC)-Formulation |
|
|
|
| 1987/07/06 |
SUPPL-36（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1987/05/06 |
SUPPL-37（补充） |
Approval |
Labeling |
|
|
|
| 1986/01/07 |
SUPPL-34（补充） |
Approval |
Labeling |
|
|
|
| 1985/09/30 |
SUPPL-31（补充） |
Approval |
Labeling |
|
|
|
| 1985/06/18 |
SUPPL-32（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1985/05/14 |
SUPPL-33（补充） |
Approval |
Manufacturing (CMC)-Formulation |
|
|
|
| 1984/10/22 |
SUPPL-29（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1984/08/30 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1981/09/28 |
SUPPL-23（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1981/06/17 |
SUPPL-24（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1981/06/17 |
SUPPL-22（补充） |
Approval |
Efficacy |
|
|
|
| 1981/06/15 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1980/07/22 |
SUPPL-21（补充） |
Approval |
Efficacy |
|
|
|
| 1979/05/15 |
SUPPL-20（补充） |
Approval |
Efficacy |
|
|
|
| 1979/01/23 |
SUPPL-19（补充） |
Approval |
Efficacy |
|
|
|
| 1979/01/16 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1977/06/09 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC)-Packaging |
|
|
|
| 1976/05/03 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1976/01/16 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1975/05/20 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1975/05/20 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
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:METHYLERGONOVINE MALEATE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:0.2MG/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 |
|---|
| 006035 |
004 |
NDA |
METHERGINE |
METHYLERGONOVINE MALEATE |
INJECTABLE;INJECTION |
0.2MG/ML |
Discontinued |
Yes |
No |
AP |
Approved Prior to Jan 1, 1982
|
EDISON THERAPS LLC |
| 090193 |
001 |
ANDA |
METHYLERGONOVINE MALEATE |
METHYLERGONOVINE MALEATE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
Yes |
AP |
2008/11/24
|
AM REGENT |
| 040889 |
001 |
ANDA |
METHYLERGONOVINE MALEATE |
METHYLERGONOVINE MALEATE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
No |
No |
AP |
2010/09/13
|
BRECKENRIDGE |
