药品注册申请号:103234
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 EPOGEN/PROCRIT EPOETIN ALFA VIAL; SINGLE-USE 10,000U/ML No No None 1989/06/01 -- Prescription
002 EPOGEN/PROCRIT EPOETIN ALFA VIAL; MULTIDOSE 20,000U/2ML No No None -- Prescription
003 EPOGEN/PROCRIT EPOETIN ALFA VIAL; MULTIDOSE 20,000/ML No No None -- Prescription
004 EPOGEN/PROCRIT EPOETIN ALFA VIAL; SINGLE-USE 2,000U/ML No No None -- Prescription
005 EPOGEN/PROCRIT EPOETIN ALFA VIAL; SINGLE-USE 3,000U/ML No No None -- Prescription
006 EPOGEN/PROCRIT EPOETIN ALFA VIAL; SINGLE-USE 40,000U/ML No No None -- Prescription
007 EPOGEN/PROCRIT EPOETIN ALFA VIAL; SINGLE-USE 4,000U/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-5378(补充) Approval Labeling STANDARD
2018/07/25 SUPPL-5369(补充) Approval Labeling STANDARD
2017/09/29 SUPPL-5366(补充) Approval Labeling STANDARD
2017/09/29 SUPPL-5363(补充) Approval Labeling STANDARD
2017/04/13 SUPPL-5364(补充) Approval Labeling STANDARD
2017/04/13 SUPPL-5360(补充) Approval Labeling STANDARD
2013/12/31 SUPPL-5323(补充) Approval Labeling STANDARD
2013/03/27 SUPPL-5329(补充) Approval Labeling STANDARD
2012/05/31 SUPPL-5281(补充) Approval Labeling STANDARD
2011/06/24 SUPPL-5266(补充) Approval Labeling STANDARD
2011/06/24 SUPPL-5256(补充) Approval Labeling STANDARD
2011/06/24 SUPPL-5166(补充) Approval Efficacy STANDARD
2010/02/16 SUPPL-5199(补充) Approval Labeling STANDARD
2010/01/11 SUPPL-5232(补充) Approval Labeling STANDARD
2009/10/13 SUPPL-5221(补充) Approval Labeling STANDARD
2008/11/19 SUPPL-5196(补充) Approval Supplement
2008/11/19 SUPPL-5195(补充) Approval Labeling STANDARD
2008/03/07 SUPPL-5164(补充) Approval Labeling STANDARD
2007/12/17 SUPPL-5163(补充) Approval Labeling STANDARD
2007/11/08 SUPPL-5158(补充) Approval Labeling STANDARD
2007/03/09 SUPPL-5122(补充) Approval Labeling STANDARD
2006/05/11 SUPPL-5104(补充) Approval Labeling STANDARD
2005/10/27 SUPPL-5082(补充) Approval Efficacy STANDARD
2005/10/26 SUPPL-5093(补充) Approval Labeling STANDARD
2004/11/10 SUPPL-5076(补充) Approval Labeling STANDARD
2004/10/19 SUPPL-1058(补充) Approval Labeling STANDARD
2004/06/30 SUPPL-5053(补充) Approval Efficacy STANDARD
2004/05/21 SUPPL-5033(补充) Approval Efficacy STANDARD
2003/05/07 SUPPL-5034(补充) Approval Labeling STANDARD
2000/09/29 SUPPL-1062(补充) Approval Labeling STANDARD
1999/07/26 SUPPL-1046(补充) Approval Supplement
1996/12/23 SUPPL-1036(补充) Approval Efficacy UNKNOWN
1994/06/29 SUPPL-1016(补充) Approval Supplement
1993/04/01 SUPPL-1015(补充) Approval Efficacy UNKNOWN
1990/12/31 SUPPL-1009(补充) Approval Supplement
1989/06/01 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity UNKNOWN ;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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