药品注册申请号:020098
申请类型:NDA (新药申请)
申请人:ABBVIE
申请人全名:ABBVIE INC
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
001 MIVACRON MIVACURIUM CHLORIDE SOLUTION;INTRAVENOUS EQ 2MG BASE/ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1992/01/22 1992/01/22 Discontinued
002 MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER MIVACURIUM CHLORIDE INJECTABLE;INJECTION EQ 0.5MG BASE/ML No No None 1992/01/22 Discontinued
003 MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER MIVACURIUM CHLORIDE INJECTABLE;INJECTION EQ 50MG BASE/100ML No No None 1992/01/22 Discontinued
004 MIVACRON MIVACURIUM CHLORIDE SOLUTION;INTRAVENOUS EQ 10MG BASE/5ML (EQ 2MG BASE/ML) Yes No None 1992/01/22 Discontinued
005 MIVACRON MIVACURIUM CHLORIDE SOLUTION;INTRAVENOUS EQ 20MG BASE/10ML (EQ 2MG BASE/ML) Yes No None 1992/01/22 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
2018/07/26 SUPPL-19(补充) Approval Labeling STANDARD
2015/01/30 SUPPL-18(补充) Approval Manufacturing (CMC) PRIORITY
2010/11/22 SUPPL-17(补充) Approval Labeling UNKNOWN
2002/10/15 SUPPL-14(补充) Approval Manufacturing (CMC) PRIORITY
2002/06/04 SUPPL-13(补充) Approval Manufacturing (CMC) PRIORITY
2001/02/20 SUPPL-12(补充) Approval Labeling STANDARD
1999/06/25 SUPPL-10(补充) Approval Labeling STANDARD
1999/03/17 SUPPL-11(补充) Approval Manufacturing (CMC) PRIORITY
1998/05/19 SUPPL-9(补充) Approval Labeling STANDARD
1997/06/04 SUPPL-8(补充) Approval Manufacturing (CMC) PRIORITY
1995/06/09 SUPPL-6(补充) Approval Manufacturing (CMC) PRIORITY
1995/02/08 SUPPL-1(补充) Approval Labeling STANDARD
1994/08/18 SUPPL-5(补充) Approval Manufacturing (CMC) PRIORITY
1994/04/15 SUPPL-3(补充) Approval Manufacturing (CMC) PRIORITY
1994/03/02 SUPPL-2(补充) Approval Labeling STANDARD
1994/01/25 SUPPL-4(补充) Approval Labeling STANDARD
1992/01/22 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity PRIORITY
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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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
本品无治疗等效药品
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