药品注册申请号:020343
申请类型:NDA (新药申请)
申请人:SANOFI AVENTIS US
申请人全名:SANOFI AVENTIS US 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
001 PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER MILRINONE LACTATE INJECTABLE;INJECTION EQ 10MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1994/08/09 1994/08/09 Discontinued
002 PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER MILRINONE LACTATE INJECTABLE;INJECTION EQ 15MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1994/08/09 Discontinued
003 PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER MILRINONE LACTATE INJECTABLE;INJECTION EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1994/08/09 Discontinued
004 PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER MILRINONE LACTATE INJECTABLE;INJECTION EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1994/08/09 Discontinued
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2007/10/30 SUPPL 21 Approval Labeling STANDARD
2007/05/01 SUPPL 20 Approval Labeling STANDARD
2003/04/09 SUPPL 14 Approval Labeling STANDARD
2002/09/16 SUPPL 13 Approval Manufacturing (CMC) STANDARD
2001/10/18 SUPPL 11 Approval Manufacturing (CMC) STANDARD
2000/11/29 SUPPL 10 Approval Labeling STANDARD
2000/05/10 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1999/07/06 SUPPL 8 Approval Labeling STANDARD
1998/10/08 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1998/02/25 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1996/08/15 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1996/08/13 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1996/06/24 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1994/11/04 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1994/08/09 ORIG 1 Approval Type 3 - New Dosage Form STANDARD
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
本品无治疗等效药品
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