药品注册申请号：050608
申请类型：NDA (新药申请)
申请人：PFIZER
申请人全名：PFIZER 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 UNASYN AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL Yes Yes AP 1986/12/31 1986/12/31 Prescription
002 UNASYN AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL Yes Yes AP 1986/12/31 Prescription
003 UNASYN AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL No No None 1986/12/31 Discontinued
005 UNASYN AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL Yes Yes AP 1993/12/10 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
1986/12/31 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity and Type 4 - New Combination STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2025/11/05 SUPPL-58（补充） Approval Labeling-Package Insert STANDARD
2025/01/31 SUPPL-56（补充） Approval Labeling-Package Insert STANDARD
2024/05/01 SUPPL-53（补充） Approval Labeling-Package Insert STANDARD
2020/10/09 SUPPL-47（补充） Approval Labeling-Package Insert STANDARD
2018/04/19 SUPPL-46（补充） Approval Labeling-Package Insert STANDARD
2017/02/13 SUPPL-44（补充） Approval Labeling-Package Insert,Labeling-Package Insert STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2015/02/09 SUPPL-43（补充） Approval Manufacturing (CMC) STANDARD
2014/11/17 SUPPL-42（补充） Approval Labeling-Package Insert STANDARD
2014/11/17 SUPPL-41（补充） Approval Labeling-Package Insert STANDARD
2012/12/14 SUPPL-38（补充） Approval Manufacturing (CMC) STANDARD
2012/03/06 SUPPL-40（补充） Approval Labeling-Package Insert STANDARD
2008/04/14 SUPPL-29（补充） Approval Labeling STANDARD
2004/08/19 SUPPL-26（补充） Approval Labeling STANDARD
2002/03/13 SUPPL-25（补充） Approval Manufacturing (CMC) STANDARD
2001/02/14 SUPPL-24（补充） Approval Manufacturing (CMC)-Control STANDARD
1998/05/29 SUPPL-23（补充） Approval Manufacturing (CMC) STANDARD
1997/02/12 SUPPL-19（补充） Approval Efficacy-New Patient Population STANDARD
1996/12/06 SUPPL-21（补充） Approval Manufacturing (CMC) STANDARD
1996/05/15 SUPPL-20（补充） Approval Manufacturing (CMC)-Control STANDARD
1993/12/10 SUPPL-18（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1993/11/05 SUPPL-17（补充） Approval Labeling STANDARD
1993/03/24 SUPPL-15（补充） Approval Manufacturing (CMC) STANDARD
1992/10/08 SUPPL-16（补充） Approval Labeling
1992/05/08 SUPPL-14（补充） Approval Manufacturing (CMC)-Control STANDARD
1992/04/23 SUPPL-13（补充） Approval Manufacturing (CMC)-Control STANDARD
1992/03/27 SUPPL-11（补充） Approval Labeling
1992/01/02 SUPPL-12（补充） Approval Manufacturing (CMC)-Control STANDARD
1991/11/22 SUPPL-9（补充） Approval Manufacturing (CMC) STANDARD
1989/08/03 SUPPL-7（补充） Approval Manufacturing (CMC) STANDARD
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
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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
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 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 Discontinued 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 Discontinued 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 ONESOURCE SPECIALTY
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
>>>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 Discontinued 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 Discontinued 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 ONESOURCE SPECIALTY
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 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 ONESOURCE SPECIALTY
090578 001 ANDA AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE;INJECTION EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL Discontinued No No AP 2016/01/11 ASTRAL
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