药品注册申请号:020377
申请类型:NDA (新药申请)
申请人:WYETH PHARMS INC
申请人全名:WYETH PHARMACEUTICALS 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 CORDARONE AMIODARONE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1995/08/03 1995/08/03 Discontinued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
2009/03/13 SUPPL-19(补充) Approval Labeling STANDARD
2009/03/13 SUPPL-11(补充) Approval Efficacy STANDARD
2006/08/28 SUPPL-20(补充) Approval Labeling STANDARD
2005/09/15 SUPPL-18(补充) Approval Labeling STANDARD
2004/11/04 SUPPL-15(补充) Approval Labeling STANDARD
2004/11/04 SUPPL-8(补充) Approval Labeling STANDARD
2004/11/04 SUPPL-7(补充) Approval Labeling STANDARD
2004/11/02 SUPPL-17(补充) Approval Labeling STANDARD
2004/09/02 SUPPL-16(补充) Approval Labeling STANDARD
2003/05/09 SUPPL-12(补充) Approval Labeling STANDARD
2003/05/09 SUPPL-10(补充) Approval Labeling STANDARD
2003/05/06 SUPPL-14(补充) Approval Labeling STANDARD
2003/05/06 SUPPL-13(补充) Approval Labeling STANDARD
2002/04/11 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
2001/07/11 SUPPL-5(补充) Approval Labeling STANDARD
2001/07/11 SUPPL-4(补充) Approval Labeling STANDARD
2001/05/02 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1998/05/14 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1997/12/10 SUPPL-2(补充) Approval Labeling STANDARD
1995/10/18 SUPPL-1(补充) Approval Labeling STANDARD ;Orphan
1995/08/03 ORIG-1(原始申请) Approval Type 3 - New Dosage Form STANDARD ;Orphan
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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