药品注册申请号:018972
申请类型:NDA (新药申请)
申请人:WYETH PHARMS
申请人全名:WYETH PHARMACEUTICALS 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 CORDARONE AMIODARONE HYDROCHLORIDE TABLET;ORAL 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1985/12/24 1985/12/24 Discontinued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
2018/10/17 SUPPL-54(补充) Approval Labeling STANDARD
2017/04/07 SUPPL-53(补充) Approval Labeling STANDARD
2016/11/22 SUPPL-52(补充) Approval Labeling STANDARD
2016/04/22 SUPPL-51(补充) Approval Labeling STANDARD
2015/03/27 SUPPL-47(补充) Approval Labeling UNKNOWN
2014/12/22 SUPPL-50(补充) Approval Labeling STANDARD
2014/01/22 SUPPL-48(补充) Approval Labeling STANDARD
2014/01/17 SUPPL-49(补充) Approval Manufacturing (CMC) PRIORITY
2012/11/20 SUPPL-46(补充) Approval Manufacturing (CMC) PRIORITY
2011/11/14 SUPPL-44(补充) Approval Labeling UNKNOWN
2010/12/13 SUPPL-42(补充) Approval Labeling UNKNOWN
2009/11/19 SUPPL-41(补充) Approval Labeling UNKNOWN
2009/09/28 SUPPL-40(补充) Approval Labeling STANDARD
2009/04/21 SUPPL-39(补充) Approval Labeling STANDARD
2009/04/21 SUPPL-38(补充) Approval Labeling STANDARD
2008/10/17 SUPPL-37(补充) Approval Labeling STANDARD
2007/11/13 SUPPL-36(补充) Approval Labeling STANDARD
2007/10/02 SUPPL-35(补充) Approval Labeling STANDARD
2007/03/30 SUPPL-34(补充) Approval Labeling STANDARD
2006/09/21 SUPPL-32(补充) Approval Labeling STANDARD
2006/08/28 SUPPL-33(补充) Approval Labeling STANDARD
2005/08/23 SUPPL-31(补充) Approval Labeling STANDARD
2004/12/03 SUPPL-30(补充) Approval Labeling STANDARD
2004/11/01 SUPPL-29(补充) Approval Labeling STANDARD
2004/09/02 SUPPL-28(补充) Approval Labeling STANDARD
2004/05/21 SUPPL-27(补充) Approval Labeling STANDARD
2004/05/21 SUPPL-22(补充) Approval Labeling STANDARD
2003/05/06 SUPPL-26(补充) Approval Labeling STANDARD
2003/04/30 SUPPL-23(补充) Approval Labeling STANDARD
2002/12/18 SUPPL-25(补充) Approval Labeling STANDARD
2002/09/20 SUPPL-24(补充) Approval Manufacturing (CMC) PRIORITY
2001/12/18 SUPPL-21(补充) Approval Labeling STANDARD
1999/10/08 SUPPL-20(补充) Approval Labeling STANDARD
1999/10/08 SUPPL-19(补充) Approval Labeling STANDARD
1999/01/05 SUPPL-17(补充) Approval Labeling STANDARD
1999/01/05 SUPPL-15(补充) Approval Labeling STANDARD
1998/06/15 SUPPL-18(补充) Approval Labeling STANDARD
1998/06/15 SUPPL-16(补充) Approval Labeling STANDARD
1995/10/18 SUPPL-14(补充) Approval Labeling STANDARD
1994/04/14 SUPPL-12(补充) Approval Labeling
1990/08/09 SUPPL-11(补充) Approval Manufacturing (CMC) PRIORITY
1990/08/09 SUPPL-10(补充) Approval Labeling
1989/07/28 SUPPL-8(补充) Approval Manufacturing (CMC) PRIORITY
1989/02/10 SUPPL-9(补充) Approval Labeling
1988/12/13 SUPPL-2(补充) Approval Manufacturing (CMC) PRIORITY
1988/09/14 SUPPL-4(补充) Approval Labeling
1988/06/29 SUPPL-7(补充) Approval Labeling
1987/10/28 SUPPL-6(补充) Approval Manufacturing (CMC) PRIORITY
1987/08/07 SUPPL-5(补充) Approval Manufacturing (CMC) PRIORITY
1987/05/15 SUPPL-3(补充) Approval Labeling
1986/10/07 SUPPL-1(补充) Approval Labeling
1985/12/24 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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