药品注册申请号：065499
申请类型：ANDA (仿制药申请)
申请人：EUGIA PHARMA SPECLTS
申请人全名：EUGIA PHARMA SPECIALITIES 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 SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 125MG BASE/VIAL No No None 2010/08/17 2010/08/17 Discontinued
002 AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 250MG BASE/VIAL No No AP 2010/08/17 Prescription
003 AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL No No AP 2010/08/17 Prescription
004 AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No AP 2010/08/17 Prescription
005 AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL No No AP 2010/08/17 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
2010/08/17 ORIG-1（原始申请） Approval
>>>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
2024/05/01 SUPPL-13（补充） Approval Labeling-Package Insert STANDARD
2024/04/24 SUPPL-11（补充） Approval Labeling-Package Insert STANDARD
2018/02/21 SUPPL-7（补充） Approval Labeling-Package Insert STANDARD
2018/02/21 SUPPL-4（补充） Approval Labeling-Package Insert 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
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; 剂型/给药途径:INJECTABLE;INJECTION; 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
061395 002 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 250MG BASE/VIAL Prescription No Yes AP Approved Prior to Jan 1, 1982 SANDOZ
062719 001 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 250MG BASE/VIAL Prescription No No AP 1987/05/12 ISTITUTO BIO ITA SPA
062772 006 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 250MG BASE/VIAL Prescription No No AP 1993/04/15 HQ SPECLT PHARMA
090354 001 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 250MG BASE/VIAL Prescription No No AP 2009/12/28 ANTIBIOTICE
065499 002 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 250MG BASE/VIAL Prescription No No AP 2010/08/17 EUGIA PHARMA SPECLTS
201025 001 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 250MG BASE/VIAL Discontinued No No AP 2014/04/09 ONESOURCE SPECIALTY
090583 002 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 250MG BASE/VIAL Prescription No No AP 2015/11/27 SAGENT PHARMS INC
>>>活性成分:AMPICILLIN SODIUM; 剂型/给药途径:INJECTABLE;INJECTION; 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
061395 003 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No Yes AP Approved Prior to Jan 1, 1982 SANDOZ
062719 003 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 1987/05/12 ISTITUTO BIO ITA SPA
062772 007 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 1993/04/15 HQ SPECLT PHARMA
090354 002 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2009/12/28 ANTIBIOTICE
065499 003 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2010/08/17 EUGIA PHARMA SPECLTS
201025 002 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL Discontinued No No AP 2014/04/09 ONESOURCE SPECIALTY
090583 003 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2015/11/27 SAGENT PHARMS INC
>>>活性成分:AMPICILLIN SODIUM; 剂型/给药途径:INJECTABLE;INJECTION; 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
061395 004 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No Yes AP Approved Prior to Jan 1, 1982 SANDOZ
062719 002 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 1987/05/12 ISTITUTO BIO ITA SPA
062772 001 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 1993/04/15 HQ SPECLT PHARMA
090354 003 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2009/12/28 ANTIBIOTICE
065499 004 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2010/08/17 EUGIA PHARMA SPECLTS
201025 003 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2014/04/09 ONESOURCE SPECIALTY
090583 004 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2015/11/27 SAGENT PHARMS INC
>>>活性成分:AMPICILLIN SODIUM; 剂型/给药途径:INJECTABLE;INJECTION; 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
061395 005 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL Prescription No Yes AP Approved Prior to Jan 1, 1982 SANDOZ
062772 003 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL Prescription No No AP 1993/04/15 HQ SPECLT PHARMA
062797 002 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL Prescription No No AP 1993/07/12 ISTITUTO BIO ITA SPA
090354 004 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL Prescription No No AP 2009/12/28 ANTIBIOTICE
065499 005 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL Prescription No No AP 2010/08/17 EUGIA PHARMA SPECLTS
201025 004 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL Prescription No No AP 2014/04/09 ONESOURCE SPECIALTY
090583 005 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL Prescription No No AP 2015/11/27 SAGENT PHARMS INC
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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