药品注册申请号:022023
申请类型:NDA (新药申请)
申请人:MERCK AND CO INC
申请人全名:MERCK AND CO 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 EMEND FOSAPREPITANT DIMEGLUMINE POWDER;INTRAVENOUS EQ 115MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 2008/01/25 2008/01/25 Discontinued
002 EMEND FOSAPREPITANT DIMEGLUMINE POWDER;INTRAVENOUS EQ 150MG BASE/VIAL Yes Yes AP 2010/11/12 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2019/11/14 SUPPL 19 Approval Labeling STANDARD
2018/04/03 SUPPL 17 Approval Efficacy PRIORITY
2018/03/26 SUPPL 18 Approval Labeling STANDARD
2017/08/09 SUPPL 16 Approval Labeling STANDARD
2017/05/31 SUPPL 15 Approval Labeling STANDARD
2016/12/02 SUPPL 14 Approval Manufacturing (CMC) N/A
2016/02/01 SUPPL 6 Approval Efficacy STANDARD
2015/01/12 SUPPL 12 Approval Manufacturing (CMC) STANDARD
2014/08/12 SUPPL 11 Approval Labeling STANDARD
2013/03/27 SUPPL 10 Approval Labeling STANDARD
2013/03/20 SUPPL 7 Approval Labeling STANDARD
2012/07/06 SUPPL 9 Approval Labeling STANDARD
2010/11/12 SUPPL 4 Approval Efficacy STANDARD
2010/03/23 SUPPL 5 Approval Labeling UNKNOWN
2010/03/23 SUPPL 3 Approval Labeling STANDARD
2010/03/23 SUPPL 2 Approval Labeling STANDARD
2009/02/02 SUPPL 1 Approval Labeling STANDARD
2008/01/25 ORIG 1 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
001 5691336 2019/03/04 Y Y PDF格式
5691336*PED 2019/09/04 PDF格式
002 5691336 2019/03/04 Y Y U-2265 PDF格式
5691336*PED 2019/09/04 PDF格式
001 5512570 2014/03/04 U-850 PDF格式**本条是由Drugfuture回溯的历史信息**
5538982 2013/07/23 U-850 PDF格式**本条是由Drugfuture回溯的历史信息**
5716942 2015/02/10 U-850 PDF格式**本条是由Drugfuture回溯的历史信息**
7214692 2012/09/18 U-850 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5512570 2014/03/04 U-850 PDF格式**本条是由Drugfuture回溯的历史信息**
5538982 2013/07/23 U-850 PDF格式**本条是由Drugfuture回溯的历史信息**
5716942 2015/02/10 U-850 PDF格式**本条是由Drugfuture回溯的历史信息**
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 NPP 2021/04/03
PED 2021/10/03
002 PED 2021/10/03
D-155 2019/02/01
NPP 2021/04/03
002 D-128 2013/11/12**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
活性成分:FOSAPREPITANT DIMEGLUMINE 剂型/给药途径:POWDER;INTRAVENOUS 规格:EQ 150MG BASE/VIAL 治疗等效代码:AP
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
022023 002 NDA EMEND FOSAPREPITANT DIMEGLUMINE POWDER;INTRAVENOUS EQ 150MG BASE/VIAL Prescription Yes Yes AP 2010/11/12 MERCK AND CO INC
206197 001 ANDA FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE POWDER;INTRAVENOUS EQ 150MG BASE/VIAL Prescription No No AP 2016/06/09 FRESENIUS KABI USA
209965 001 ANDA FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE POWDER;INTRAVENOUS EQ 150MG BASE/VIAL Prescription No No AP 2019/09/05 MSN LABS PVT LTD
210689 001 ANDA FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE POWDER;INTRAVENOUS EQ 150MG BASE/VIAL Prescription No No AP 2019/09/05 LUPIN LTD
211624 001 ANDA FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE POWDER;INTRAVENOUS EQ 150MG BASE/VIAL Prescription No No AP 2019/09/05 SUNGEN PHARMA
211860 001 ANDA FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE POWDER;INTRAVENOUS EQ 150MG BASE/VIAL Prescription No No AP 2019/09/05 BAXTER HLTHCARE CORP
212309 001 ANDA FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE POWDER;INTRAVENOUS EQ 150MG BASE/VIAL Prescription No No AP 2019/09/05 BE PHARMS
204015 002 ANDA FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE POWDER;INTRAVENOUS EQ 150MG BASE/VIAL Prescription No No AP 2019/09/05 MYLAN LABS LTD
205020 001 ANDA FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE POWDER;INTRAVENOUS EQ 150MG BASE/VIAL Prescription No No AP 2019/09/05 APOTEX
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