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 |
2013/05/21 |
SUPPL-79(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2012/06/25 |
SUPPL-78(补充) |
Approval |
Labeling |
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) |
|
|
|
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) |
|
|
|
1997/07/15 |
SUPPL-61(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
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) |
|
|
|
1995/09/22 |
SUPPL-56(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/09/22 |
SUPPL-55(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/03/22 |
SUPPL-50(补充) |
Approval |
Labeling |
|
|
|
1994/07/18 |
SUPPL-51(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/07/07 |
SUPPL-54(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
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) |
|
|
|
1989/10/20 |
SUPPL-47(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/10/20 |
SUPPL-46(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/10/20 |
SUPPL-44(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/10/20 |
SUPPL-43(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/03/02 |
SUPPL-42(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/07/06 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
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) |
|
|
|
1985/05/14 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/10/22 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/08/30 |
SUPPL-30(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1981/09/28 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1981/06/17 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
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) |
|
|
|
1977/06/09 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1976/05/03 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1976/01/16 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1975/05/20 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1975/05/20 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1946/11/19 |
ORIG-1(原始申请) |
Approval |
|
UNKNOWN
|
|
|
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 |