药品注册申请号：090579
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 AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL No No AP 2016/01/08 2016/01/08 Discontinued
002 AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL No No AP 2016/01/08 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
2022/09/13 SUPPL-8（补充） Approval Labeling STANDARD
2020/05/04 SUPPL-5（补充） Approval Labeling STANDARD
2020/05/04 SUPPL-4（补充） Approval Labeling STANDARD
2016/01/08 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:AMPICILLIN SODIUM; SULBACTAM SODIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 1GM BASE/VIAL;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
050608 002 NDA UNASYN AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL Prescription Yes Yes AP 1986/12/31 PFIZER
062901 001 ANDA UNASYN AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL Discontinued No No AP 1988/11/23 PFIZER
065074 001 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL Prescription No No AP 2002/03/19 HIKMA
065222 001 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL Prescription No No AP 2005/11/29 ISTITUTO BIO ITA SPA
065176 001 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL Prescription No No AP 2005/11/30 HQ SPECLT PHARMA
065241 001 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL Prescription No No AP 2006/07/25 SANDOZ
065310 001 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL Prescription No No AP 2006/07/25 SANDOZ
065406 001 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL Prescription No No AP 2009/12/22 ACS DOBFAR
090349 001 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL Prescription No No AP 2010/09/20 EUGIA PHARMA SPECLTS
201024 001 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL Prescription No No AP 2014/04/07 STERISCIENCE SPECLTS
201406 001 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL Prescription No No AP 2015/12/07 ANTIBIOTICE
090579 001 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL Discontinued No No AP 2016/01/08 ASTRAL
活性成分:AMPICILLIN SODIUM; SULBACTAM SODIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 2GM BASE/VIAL;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
050608 001 NDA UNASYN AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL Prescription Yes Yes AP 1986/12/31 PFIZER
062901 002 ANDA UNASYN AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL Discontinued No No AP 1992/02/27 PFIZER
065074 002 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL Prescription No No AP 2002/03/19 HIKMA
065222 002 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL Prescription No No AP 2005/11/29 ISTITUTO BIO ITA SPA
065176 002 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL Prescription No No AP 2005/11/30 HQ SPECLT PHARMA
065241 002 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL Prescription No No AP 2006/07/25 SANDOZ
065310 002 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL Prescription No No AP 2006/07/25 SANDOZ
065406 002 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL Prescription No No AP 2009/12/22 ACS DOBFAR
090349 002 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL Prescription No No AP 2010/09/20 EUGIA PHARMA SPECLTS
201024 002 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL Prescription No No AP 2014/04/07 STERISCIENCE SPECLTS
201406 002 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL Prescription No No AP 2015/12/07 ANTIBIOTICE
090579 002 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL Discontinued No No AP 2016/01/08 ASTRAL
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药品NDC数据与药品包装、标签说明书
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