药品注册申请号:021135
申请类型:NDA (新药申请)
申请人:AM REGENT
申请人全名:AMERICAN REGENT 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 VENOFER FERRIC OXYHYDROXIDE INJECTABLE;INTRAVENOUS EQ 100MG IRON/5ML (EQ 20MG IRON/ML) Yes Yes None 2000/11/06 2000/11/06 Prescription
002 VENOFER FERRIC OXYHYDROXIDE INJECTABLE;INTRAVENOUS EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) Yes No None 2005/03/20 Prescription
003 VENOFER FERRIC OXYHYDROXIDE INJECTABLE;INTRAVENOUS EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML) No No None 2005/03/29 Discontinued
004 VENOFER FERRIC OXYHYDROXIDE INJECTABLE;INTRAVENOUS EQ 200MG IRON/10ML (EQ 20MG IRON/ML) Yes No None 2007/02/09 Prescription
005 VENOFER FERRIC OXYHYDROXIDE INJECTABLE;INTRAVENOUS EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML) No No None 2013/03/29 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
2024/08/01 SUPPL-38(补充) Approval Labeling STANDARD
2021/01/20 SUPPL-37(补充) Approval Labeling STANDARD
2020/09/11 SUPPL-36(补充) Approval Labeling STANDARD
2018/12/19 SUPPL-35(补充) Approval Labeling STANDARD
2017/11/28 SUPPL-32(补充) Approval Labeling STANDARD
2016/06/13 SUPPL-29(补充) Approval Manufacturing (CMC) STANDARD
2016/05/27 SUPPL-31(补充) Approval Manufacturing (CMC) STANDARD
2016/03/02 SUPPL-26(补充) Approval Manufacturing (CMC) STANDARD
2015/05/13 SUPPL-28(补充) Approval Manufacturing (CMC) STANDARD
2014/06/13 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
2013/03/29 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
2012/09/21 SUPPL-24(补充) Approval Efficacy STANDARD
2011/06/22 SUPPL-20(补充) Approval Labeling STANDARD
2007/12/03 SUPPL-17(补充) Approval Labeling STANDARD
2007/02/09 SUPPL-15(补充) Approval Manufacturing (CMC) N/A
2005/10/17 SUPPL-13(补充) Approval Efficacy UNKNOWN
2005/06/17 SUPPL-8(补充) Approval Efficacy STANDARD
2005/03/29 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
2003/06/02 SUPPL-6(补充) Approval Efficacy STANDARD
2002/12/05 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
2002/07/26 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
2002/01/22 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
2001/02/13 SUPPL-1(补充) Approval Labeling STANDARD
2000/11/06 ORIG-1(原始申请) 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
001 I-459 2008/06/17**本条是由Drugfuture回溯的历史信息**
I-474 2008/10/17**本条是由Drugfuture回溯的历史信息**
NPP 2015/09/21**本条是由Drugfuture回溯的历史信息**
002 I-459 2008/06/17**本条是由Drugfuture回溯的历史信息**
I-474 2008/10/17**本条是由Drugfuture回溯的历史信息**
NPP 2015/09/21**本条是由Drugfuture回溯的历史信息**
003 I-459 2008/06/17**本条是由Drugfuture回溯的历史信息**
I-474 2008/10/17**本条是由Drugfuture回溯的历史信息**
004 I-459 2008/06/17**本条是由Drugfuture回溯的历史信息**
I-474 2008/10/17**本条是由Drugfuture回溯的历史信息**
005 NPP 2015/09/21**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
本品无治疗等效药品
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