药品注册申请号:203704
申请类型:ANDA (仿制药申请)
申请人:QILU
申请人全名:QILU PHARMACEUTICAL CO 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 CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE INJECTABLE;INJECTION EQ 500MG BASE/VIAL No Yes AP 2016/02/01 2016/02/01 Prescription
002 CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL No Yes AP 2016/02/01 Prescription
003 CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL No Yes AP 2016/02/01 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
2022/01/28 SUPPL-14(补充) Approval Labeling STANDARD
2020/02/11 SUPPL-7(补充) Approval Labeling STANDARD
2017/08/15 SUPPL-4(补充) Approval Labeling STANDARD
2017/08/15 SUPPL-2(补充) Approval Labeling STANDARD
2016/02/01 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
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:CEFEPIME HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 500MG 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
203704 001 ANDA CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No Yes AP 2016/02/01 QILU
活性成分:CEFEPIME HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 1GM 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
065441 001 ANDA CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2008/03/20 ACS DOBFAR
203704 002 ANDA CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No Yes AP 2016/02/01 QILU
091048 001 ANDA CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2017/01/04 SAGENT PHARMS INC
212721 001 ANDA CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Discontinued No No AP 2020/07/21 ASTRAL
214402 001 ANDA CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2024/05/22 HIKMA
活性成分:CEFEPIME HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 2GM 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
065441 002 ANDA CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL Prescription No No AP 2008/03/20 ACS DOBFAR
203704 003 ANDA CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL Prescription No Yes AP 2016/02/01 QILU
091048 002 ANDA CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL Prescription No No AP 2017/01/04 SAGENT PHARMS INC
212721 002 ANDA CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL Discontinued No No AP 2020/07/21 ASTRAL
214402 002 ANDA CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL Prescription No No AP 2024/05/22 HIKMA
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药品NDC数据与药品包装、标签说明书
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