药品注册申请号：204702
申请类型：ANDA (仿制药申请)
申请人：EUGIA PHARMA
申请人全名：EUGIA PHARMA SPECIALITIES LTD
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 PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE INJECTABLE;INTRAVENOUS EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) No No AP 2018/11/06 2018/11/06 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
2018/11/06 ORIG-1（原始申请） Approval
>>>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
2025/03/25 SUPPL-2（补充） Approval Labeling-Package Insert,Labeling-Patient Package Insert 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:PALONOSETRON HYDROCHLORIDE; 剂型/给药途径:INJECTABLE;INTRAVENOUS; 规格:EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML); 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
202521 001 ANDA PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE INJECTABLE;INTRAVENOUS EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Prescription No No AP 2015/10/13 SANDOZ
201533 002 ANDA PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE INJECTABLE;INTRAVENOUS EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Prescription No Yes AP 2016/04/21 DR REDDYS
090713 001 ANDA PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE INJECTABLE;INTRAVENOUS EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Prescription No No AP 2018/03/23 TEVA PHARMS USA
205648 001 ANDA PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE INJECTABLE;INTRAVENOUS EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Prescription No No AP 2018/09/19 QILU PHARM HAINAN
205870 001 ANDA PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE INJECTABLE;INTRAVENOUS EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Prescription No No AP 2018/09/19 SAGENT PHARMS INC
206396 001 ANDA PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE INJECTABLE;INTRAVENOUS EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Discontinued No No AP 2018/09/19 CIPLA
206416 001 ANDA PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE INJECTABLE;INTRAVENOUS EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Prescription No No AP 2018/09/19 MYLAN INSTITUTIONAL
206801 001 ANDA PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE INJECTABLE;INTRAVENOUS EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Prescription No No AP 2018/09/19 FRESENIUS KABI USA
206802 001 ANDA PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE INJECTABLE;INTRAVENOUS EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Prescription No No AP 2018/09/19 FRESENIUS KABI USA
204289 001 ANDA PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE INJECTABLE;INTRAVENOUS EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Prescription No No AP 2018/09/19 SAGENT PHARMS INC
207005 001 ANDA PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE INJECTABLE;INTRAVENOUS EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Prescription No No AP 2018/09/19 HOSPIRA
209287 001 ANDA PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE INJECTABLE;INTRAVENOUS EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Prescription No No AP 2018/09/19 CHARTWELL RX
204702 001 ANDA PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE INJECTABLE;INTRAVENOUS EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Prescription No No AP 2018/11/06 EUGIA PHARMA
208789 001 ANDA PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE INJECTABLE;INTRAVENOUS EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Discontinued No No AP 2020/05/22 NOVAST LABS
202951 002 ANDA PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE INJECTABLE;INTRAVENOUS EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Prescription No No AP 2021/06/29 AVET LIFESCIENCES
206916 001 ANDA PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE INJECTABLE;INTRAVENOUS EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Prescription No No AP 2021/11/12 BAXTER HLTHCARE CORP
215861 001 ANDA PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE INJECTABLE;INTRAVENOUS EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Prescription No No AP 2023/08/14 MEITHEAL
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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