药品注册申请号:006035
申请类型:NDA (新药申请)
申请人:EDISON THERAPS LLC
申请人全名:EDISON THERAPEUTICS LLC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
003 METHERGINE METHYLERGONOVINE MALEATE TABLET;ORAL 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1946/11/19 Approved Prior to Jan 1, 1982 Discontinued
004 METHERGINE METHYLERGONOVINE MALEATE INJECTABLE;INJECTION 0.2MG/ML Yes No AP Approved Prior to Jan 1, 1982 Discontinued
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
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
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RLDRSTE 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
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