药品注册申请号:065240
申请类型:ANDA (仿制药申请)
申请人:SANDOZ
申请人全名:SANDOZ INC
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 10GM BASE/VIAL;EQ 5GM BASE/VIAL No No AP 2006/07/25 2006/07/25 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
2021/06/21 SUPPL-23(补充) Approval Labeling STANDARD
2020/05/14 SUPPL-19(补充) Approval Labeling STANDARD
2020/05/14 SUPPL-17(补充) Approval Labeling STANDARD
2015/03/01 SUPPL-13(补充) Approval Labeling STANDARD
2015/03/01 SUPPL-12(补充) Approval Labeling STANDARD
2013/07/31 SUPPL-11(补充) Approval Labeling STANDARD
2007/10/31 SUPPL-3(补充) Approval Manufacturing (CMC)
2006/07/25 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:AMPICILLIN SODIUM; SULBACTAM SODIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 10GM BASE/VIAL;EQ 5GM 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 005 NDA UNASYN AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL Prescription Yes Yes AP 1993/12/10 PFIZER
065076 001 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL Prescription No No AP 2002/03/19 HIKMA
065188 001 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL Prescription No No AP 2005/11/25 HQ SPECLT PHARMA
065240 001 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL Prescription No No AP 2006/07/25 SANDOZ
065314 001 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL Prescription No No AP 2006/11/27 ISTITUTO BIO ITA SPA
065403 001 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL Prescription No No AP 2009/12/23 ACS DOBFAR
090339 001 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL Prescription No No AP 2010/09/20 EUGIA PHARMA SPECLTS
202197 001 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL Prescription No No AP 2014/04/07 STERISCIENCE
090578 001 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL Prescription No No AP 2016/01/11 ASTRAL
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