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DIMEGLUMINE POWDER;INTRAVENOUS EQ 115MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2008/01/25 2008/01/25 Discontinued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
批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2008/01/25 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2022/05/02 SUPPL-21（补充） Approval Efficacy-New Dosing Regimen STANDARD
2019/11/14 SUPPL-19（补充） Approval Labeling-Package Insert STANDARD
2018/04/03 SUPPL-17（补充） Approval Efficacy-New Patient Population PRIORITY
2018/03/26 SUPPL-18（补充） Approval Labeling-Package Insert STANDARD
2017/08/09 SUPPL-16（补充） Approval Labeling-Package Insert STANDARD
2017/05/31 SUPPL-15（补充） Approval Labeling-Package Insert STANDARD
2016/12/02 SUPPL-14（补充） Approval Manufacturing (CMC)-Manufacturing Process N/A
2016/02/01 SUPPL-6（补充） Approval Efficacy-New Dosing Regimen STANDARD
2015/01/12 SUPPL-12（补充） Approval Manufacturing (CMC) STANDARD
2014/08/12 SUPPL-11（补充） Approval Labeling-Package Insert STANDARD
2013/03/27 SUPPL-10（补充） Approval Labeling-Package Insert STANDARD
2013/03/20 SUPPL-7（补充） Approval Labeling-Patient Package Insert,Labeling-Package Insert,Labeling-Package Insert STANDARD
2012/07/06 SUPPL-9（补充） Approval Labeling-Package Insert STANDARD
2010/11/12 SUPPL-4（补充） Approval Efficacy-New Dosing Regimen STANDARD
2010/03/23 SUPPL-5（补充） Approval Labeling-Package Insert UNKNOWN
2010/03/23 SUPPL-3（补充） Approval Labeling-Package Insert STANDARD
2010/03/23 SUPPL-2（补充） Approval Labeling STANDARD
2009/02/02 SUPPL-1（补充） Approval Labeling 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 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**
5691336 2014/03/04 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
5691336 2019/03/04 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
5691336*PED 2019/09/04 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**
5691336 2019/03/04 Y Y U-2265 PDF格式**本条是由Drugfuture回溯的历史信息**
5691336*PED 2019/09/04 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 D-186 2025/05/02
002 D-186 2025/05/02
001 NPP 2021/04/03**本条是由Drugfuture回溯的历史信息**
PED 2021/10/03**本条是由Drugfuture回溯的历史信息**
002 D-128 2013/11/12**本条是由Drugfuture回溯的历史信息**
D-155 2019/02/01**本条是由Drugfuture回溯的历史信息**
NPP 2021/04/03**本条是由Drugfuture回溯的历史信息**
PED 2021/10/03**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
210689 001 ANDA FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE POWDER;INTRAVENOUS EQ 150MG BASE/VIAL Discontinued No No AP 2019/09/05 LUPIN LTD
204015 002 ANDA FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE POWDER;INTRAVENOUS EQ 150MG BASE/VIAL Prescription No No AP 2019/09/05 MYLAN LABS LTD
212309 001 ANDA FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE POWDER;INTRAVENOUS EQ 150MG BASE/VIAL Prescription No No AP 2019/09/05 BE PHARMS
211860 001 ANDA FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE POWDER;INTRAVENOUS EQ 150MG BASE/VIAL Prescription No No AP 2019/09/05 BAXTER HLTHCARE CORP
205020 001 ANDA FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE POWDER;INTRAVENOUS EQ 150MG BASE/VIAL Discontinued No No AP 2019/09/05 APOTEX
212957 002 ANDA FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE POWDER;INTRAVENOUS EQ 150MG BASE/VIAL Discontinued No No AP 2020/08/20 NAVINTA LLC
204025 001 ANDA FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE POWDER;INTRAVENOUS EQ 150MG BASE/VIAL Discontinued No No AP 2020/08/26 ACCORD HLTHCARE
213106 001 ANDA FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE POWDER;INTRAVENOUS EQ 150MG BASE/VIAL Prescription No No AP 2020/09/08 QILU PHARM HAINAN
203939 001 ANDA FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE POWDER;INTRAVENOUS EQ 150MG BASE/VIAL Discontinued No No AP 2020/12/08 SANDOZ
211160 001 ANDA FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE POWDER;INTRAVENOUS EQ 150MG BASE/VIAL Prescription No No AP 2020/12/09 DR REDDYS
210625 001 ANDA FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE POWDER;INTRAVENOUS EQ 150MG BASE/VIAL Prescription No No AP 2021/01/12 EUGIA PHARMA
212143 001 ANDA FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE POWDER;INTRAVENOUS EQ 150MG BASE/VIAL Prescription No No AP 2021/03/03 CHIA TAI TIANQING
214616 001 ANDA FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE POWDER;INTRAVENOUS EQ 150MG BASE/VIAL Prescription No No AP 2021/07/29 ASPIRO
214683 001 ANDA FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE POWDER;INTRAVENOUS EQ 150MG BASE/VIAL Discontinued No No AP 2023/05/16 PIRAMAL CRITICAL
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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