药品注册申请号：205020
申请类型：ANDA (仿制药申请)
申请人：APOTEX
申请人全名：APOTEX 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 FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE POWDER;INTRAVENOUS EQ 150MG BASE/VIAL No No AP 2019/09/05 2019/09/05 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
2024/10/25 SUPPL-3（补充） Approval Labeling STANDARD
2019/09/05 ORIG-1（原始申请） Approval 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
无
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
无
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 Prescription 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 Prescription 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
参考引用2
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