药品注册申请号:065222
申请类型:ANDA (仿制药申请)
申请人:ISTITUTO BIO ITA SPA
申请人全名:ISTITUTO BIOCHIMICO ITALIANO SPA
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 2005/11/29 2005/11/29 Prescription
002 AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL No No AP 2005/11/29 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
2005/11/29 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)
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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: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
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 Prescription 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
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 Prescription No No AP 2016/01/08 ASTRAL
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