药品注册申请号：091049
申请类型：ANDA (仿制药申请)
申请人：ASTRAL
申请人全名：ASTRAL STERITECH PVT 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 CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 250MG BASE/VIAL No No AP 2018/06/11 2018/06/11 Discontinued
002 CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 500MG BASE/VIAL No No AP 2018/06/11 Discontinued
003 CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 1GM BASE/VIAL No No AP 2018/06/11 Discontinued
004 CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 2GM BASE/VIAL No No AP 2018/06/11 Discontinued
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
2022/01/13 SUPPL-6（补充） Approval Labeling STANDARD
2018/06/11 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:CEFTRIAXONE SODIUM 剂型/给药途径:INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 规格:EQ 250MG 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
065169 001 ANDA CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 250MG BASE/VIAL Prescription No Yes AP 2005/05/09 SANDOZ
065391 001 ANDA CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 250MG BASE/VIAL Prescription No No AP 2007/04/12 WOCKHARDT
065342 001 ANDA CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 250MG BASE/VIAL Prescription No No AP 2008/01/10 HIKMA FARMACEUTICA
065305 001 ANDA CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 250MG BASE/VIAL Prescription No No AP 2008/01/11 EPIC PHARMA LLC
203702 001 ANDA CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 250MG BASE/VIAL Prescription No No AP 2016/06/29 QILU
091049 001 ANDA CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 250MG BASE/VIAL Discontinued No No AP 2018/06/11 ASTRAL
210197 001 ANDA CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 250MG BASE/VIAL Discontinued No No AP 2024/01/12 DEVA HOLDING AS
活性成分:CEFTRIAXONE SODIUM 剂型/给药途径:INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 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
065169 002 ANDA CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 500MG BASE/VIAL Prescription No Yes AP 2005/05/09 SANDOZ
065391 002 ANDA CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 500MG BASE/VIAL Prescription No No AP 2007/04/12 WOCKHARDT
065342 002 ANDA CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 500MG BASE/VIAL Prescription No No AP 2008/01/10 HIKMA FARMACEUTICA
065305 002 ANDA CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 500MG BASE/VIAL Prescription No No AP 2008/01/11 EPIC PHARMA LLC
203702 002 ANDA CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 500MG BASE/VIAL Prescription No No AP 2016/06/29 QILU
091049 002 ANDA CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 500MG BASE/VIAL Discontinued No No AP 2018/06/11 ASTRAL
210197 002 ANDA CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 500MG BASE/VIAL Discontinued No No AP 2024/01/12 DEVA HOLDING AS
活性成分:CEFTRIAXONE SODIUM 剂型/给药途径:INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 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
065169 003 ANDA CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 1GM BASE/VIAL Prescription No Yes AP 2005/05/09 SANDOZ
065342 003 ANDA CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 1GM BASE/VIAL Prescription No No AP 2008/01/10 HIKMA FARMACEUTICA
065305 003 ANDA CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 1GM BASE/VIAL Prescription No No AP 2008/01/11 EPIC PHARMA LLC
203702 003 ANDA CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 1GM BASE/VIAL Prescription No No AP 2016/06/29 QILU
091049 003 ANDA CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 1GM BASE/VIAL Discontinued No No AP 2018/06/11 ASTRAL
210197 003 ANDA CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 1GM BASE/VIAL Discontinued No No AP 2024/01/12 DEVA HOLDING AS
活性成分:CEFTRIAXONE SODIUM 剂型/给药途径:INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 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
065169 004 ANDA CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 2GM BASE/VIAL Prescription No Yes AP 2005/05/09 SANDOZ
065391 003 ANDA CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 2GM BASE/VIAL Prescription No No AP 2007/04/12 WOCKHARDT
065342 004 ANDA CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 2GM BASE/VIAL Prescription No No AP 2008/01/10 HIKMA FARMACEUTICA
065305 004 ANDA CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 2GM BASE/VIAL Prescription No No AP 2008/01/11 EPIC PHARMA LLC
203702 004 ANDA CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 2GM BASE/VIAL Prescription No No AP 2016/06/29 QILU
091049 004 ANDA CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 2GM BASE/VIAL Discontinued No No AP 2018/06/11 ASTRAL
210197 004 ANDA CEFTRIAXONE CEFTRIAXONE SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 2GM BASE/VIAL Discontinued No No AP 2024/01/12 DEVA HOLDING AS
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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