药品注册申请号:103951
申请类型:BLA (生物制品许可申请)
申请人:AMGEN
申请人全名:--
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 ARANESP DARBEPOETIN ALFA VIAL; INTRAVENOUS 25UG/ML No No None 2001/09/17 -- Prescription
002 ARANESP DARBEPOETIN ALFA VIAL; INTRAVENOUS 40UG/ML No No None -- Prescription
003 ARANESP DARBEPOETIN ALFA VIAL; INTRAVENOUS 60UG/ML No No None -- Prescription
004 ARANESP DARBEPOETIN ALFA VIAL; INTRAVENOUS 100UG/ML No No None -- Prescription
005 ARANESP DARBEPOETIN ALFA VIAL; INTRAVENOUS 200UG/ML No No None -- Prescription
006 ARANESP DARBEPOETIN ALFA VIAL; SUBCUTANEOUS 25UG/ML No No None -- Prescription
007 ARANESP DARBEPOETIN ALFA VIAL; SUBCUTANEOUS 40UG/ML No No None -- Prescription
008 ARANESP DARBEPOETIN ALFA VIAL; SUBCUTANEOUS 60UG/ML No No None -- Prescription
009 ARANESP DARBEPOETIN ALFA VIAL; SUBCUTANEOUS 100UG/ML No No None -- Prescription
010 ARANESP DARBEPOETIN ALFA VIAL; SUBCUTANEOUS 200UG/ML No No None -- Prescription
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
2024/04/30 SUPPL-5383(补充) Approval Labeling STANDARD
2019/01/30 SUPPL-5378(补充) Approval Efficacy PRIORITY
2018/12/20 SUPPL-5377(补充) Approval Labeling STANDARD
2017/10/31 SUPPL-5374(补充) Approval Labeling STANDARD
2017/04/13 SUPPL-5375(补充) Approval Labeling STANDARD
2016/04/27 SUPPL-5370(补充) Approval Labeling STANDARD
2015/07/23 SUPPL-5363(补充) Approval Efficacy STANDARD
2014/04/17 SUPPL-5353(补充) Approval Labeling
2013/12/31 SUPPL-5349(补充) Approval Labeling STANDARD
2013/12/31 SUPPL-5325(补充) Approval Labeling STANDARD
2013/03/27 SUPPL-5337(补充) Approval Labeling STANDARD
2012/05/31 SUPPL-5285(补充) Approval Labeling STANDARD
2011/06/24 SUPPL-5258(补充) Approval Labeling STANDARD
2011/06/24 SUPPL-5248(补充) Approval Labeling STANDARD
2011/06/24 SUPPL-5173(补充) Approval Efficacy STANDARD
2010/02/16 SUPPL-5197(补充) Approval Labeling STANDARD
2010/01/11 SUPPL-5223(补充) Approval Labeling STANDARD
2009/10/13 SUPPL-5211(补充) Approval Labeling STANDARD
2008/11/19 SUPPL-5195(补充) Approval Labeling STANDARD
2008/05/05 SUPPL-5111(补充) Approval Efficacy STANDARD
2008/03/07 SUPPL-5170(补充) Approval Labeling STANDARD
2007/12/17 SUPPL-5169(补充) Approval Labeling STANDARD
2007/11/13 SUPPL-5154(补充) Approval Labeling STANDARD
2007/11/08 SUPPL-5164(补充) Approval Labeling STANDARD
2007/04/10 SUPPL-5135(补充) Approval Labeling STANDARD
2007/03/09 SUPPL-5139(补充) Approval Labeling STANDARD
2006/03/23 SUPPL-5097(补充) Approval Efficacy STANDARD
2005/12/15 SUPPL-5088(补充) Approval Efficacy STANDARD
2005/10/26 SUPPL-5096(补充) Approval Labeling STANDARD
2005/03/24 SUPPL-5090(补充) Approval Labeling STANDARD
2004/12/16 SUPPL-5069(补充) Approval Labeling STANDARD
2004/11/18 SUPPL-5075(补充) Approval Labeling STANDARD
2002/07/19 SUPPL-5001(补充) Approval Efficacy STANDARD
2001/09/17 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity 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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