药品注册申请号:212435
申请类型:ANDA (仿制药申请)
申请人:GLAND PHARMA LTD
申请人全名:GLAND PHARMA 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 METRONIDAZOLE IN PLASTIC CONTAINER METRONIDAZOLE INJECTABLE;INJECTION 500MG/100ML No No AP 2020/08/03 2020/08/03 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
2023/10/17 SUPPL-4(补充) Approval Labeling STANDARD
2023/10/17 SUPPL-2(补充) Approval Labeling STANDARD
2023/10/17 SUPPL-1(补充) Approval Labeling STANDARD
2020/08/03 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
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
与本品治疗等效的药品
活性成分:METRONIDAZOLE 剂型/给药途径:INJECTABLE;INJECTION 规格:500MG/100ML 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
018657 001 NDA FLAGYL I.V. RTU IN PLASTIC CONTAINER METRONIDAZOLE INJECTABLE;INJECTION 500MG/100ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 BAXTER HLTHCARE
018900 001 NDA METRO I.V. IN PLASTIC CONTAINER METRONIDAZOLE INJECTABLE;INJECTION 500MG/100ML Prescription Yes Yes AP 1983/09/29 B BRAUN
018890 002 NDA METRONIDAZOLE IN PLASTIC CONTAINER METRONIDAZOLE INJECTABLE;INJECTION 500MG/100ML Prescription Yes Yes AP 1983/11/18 HOSPIRA
078084 001 ANDA METRONIDAZOLE IN PLASTIC CONTAINER METRONIDAZOLE INJECTABLE;INJECTION 500MG/100ML Prescription No No AP 2008/03/31 BAXTER HLTHCARE CORP
206191 001 ANDA METRONIDAZOLE IN PLASTIC CONTAINER METRONIDAZOLE INJECTABLE;INJECTION 500MG/100ML Prescription No No AP 2019/02/25 INFORLIFE
212435 001 ANDA METRONIDAZOLE IN PLASTIC CONTAINER METRONIDAZOLE INJECTABLE;INJECTION 500MG/100ML Prescription No No AP 2020/08/03 GLAND PHARMA LTD
217665 001 ANDA METRONIDAZOLE IN PLASTIC CONTAINER METRONIDAZOLE INJECTABLE;INJECTION 500MG/100ML Prescription No No AP 2023/05/24 AMNEAL
更多信息
药品NDC数据与药品包装、标签说明书
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