药品注册申请号：077187
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 GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML (EQ 1MG BASE/ML) No No AP 2008/06/30 2008/06/30 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
2014/09/18 SUPPL-5（补充） Approval Labeling STANDARD
2014/08/29 SUPPL-4（补充） Approval Labeling STANDARD
2008/06/30 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:GRANISETRON HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 1MG BASE/ML (EQ 1MG 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
077187 001 ANDA GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML (EQ 1MG BASE/ML) Prescription No No AP 2008/06/30 HIKMA
078096 001 ANDA GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE GRANISETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML (EQ 1MG BASE/ML) Prescription No Yes AP 2008/06/30 FRESENIUS KABI USA
078258 001 ANDA GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML (EQ 1MG BASE/ML) Prescription No No AP 2008/06/30 AMNEAL
078835 001 ANDA GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML (EQ 1MG BASE/ML) Prescription No No AP 2008/06/30 SANDOZ INC
078863 002 ANDA GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE GRANISETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML (EQ 1MG BASE/ML) Prescription No No AP 2008/06/30 BIONPHARMA
078531 001 ANDA GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML (EQ 1MG BASE/ML) Prescription No No AP 2009/04/30 SANDOZ
079078 001 ANDA GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML (EQ 1MG BASE/ML) Prescription No No AP 2009/09/14 RISING
078629 001 ANDA GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML (EQ 1MG BASE/ML) Prescription No No AP 2009/12/23 HIKMA FARMACEUTICA
091136 002 ANDA GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML (EQ 1MG BASE/ML) Prescription No No AP 2010/04/09 MYLAN ASI
204238 001 ANDA GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML (EQ 1MG BASE/ML) Discontinued No No AP 2016/07/06 EUGIA PHARMA
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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