药品注册申请号：077541
申请类型：ANDA (仿制药申请)
申请人：HIKMA
申请人全名：HIKMA PHARMACEUTICALS USA 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 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/ML No No AP 2006/12/26 2006/12/26 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
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
2021/08/16 SUPPL-21（补充） Approval Labeling STANDARD
2021/08/16 SUPPL-13（补充） Approval Labeling STANDARD
2014/12/10 SUPPL-11（补充） Approval Labeling STANDARD
2014/12/10 SUPPL-7（补充） Approval Labeling STANDARD
2013/04/03 SUPPL-5（补充） Approval Labeling STANDARD
2013/04/03 SUPPL-4（补充） Approval Labeling STANDARD
2010/11/30 SUPPL-2（补充） Approval Labeling
2006/12/26 ORIG-1（原始申请） Approval
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:ONDANSETRON HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 2MG 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
076876 001 ANDA ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/ML Discontinued No No AP 2006/11/22 TEVA
076967 001 ANDA ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2006/12/26 HIKMA
076972 001 ANDA ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2006/12/26 FRESENIUS KABI USA
076974 001 ANDA ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2006/12/26 FRESENIUS KABI USA
077011 001 ANDA ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2006/12/26 HIKMA
077365 001 ANDA ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2006/12/26 HIKMA
077473 001 ANDA ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2006/12/26 HOSPIRA
077541 001 ANDA ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2006/12/26 HIKMA
077548 001 ANDA ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2006/12/26 HOSPIRA
077577 001 ANDA ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2006/12/26 WOCKHARDT
077716 001 ANDA ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2006/12/26 WOCKHARDT
076781 001 ANDA ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2006/12/26 HIKMA FARMACEUTICA
077551 001 ANDA ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2007/06/27 SANDOZ
077430 001 ANDA ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2007/06/27 SANDOZ
079224 001 ANDA ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2009/09/25 GLAND PHARMA LTD
090648 001 ANDA ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No Yes AP 2012/06/15 GLAND PHARMA LTD
202599 001 ANDA ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/ML Discontinued No No AP 2012/12/21 EUGIA PHARMA
202600 001 ANDA ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/ML Discontinued No No AP 2012/12/21 EUGIA PHARMA
078287 001 ANDA ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No Yes AP 2013/02/22 BAXTER HLTHCARE CORP
202253 001 ANDA ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2013/07/19 FRESENIUS KABI USA
203711 001 ANDA ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No Yes AP 2014/09/08 QILU PHARM HAINAN
206846 001 ANDA ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2015/07/13 ACCORD HLTHCARE
206845 001 ANDA ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2016/03/10 ACCORD HLTHCARE
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
©2006-2024 DrugFuture->U.S. FDA Drugs Database