药品注册申请号：062719
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 SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 250MG BASE/VIAL No No AP 1987/05/12 1987/05/12 Prescription
002 AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No AP 1987/05/12 Prescription
003 AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL No No AP 1987/05/12 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
2024/03/29 SUPPL-12（补充） Approval Labeling STANDARD
2018/02/15 SUPPL-10（补充） Approval Labeling STANDARD
2018/02/15 SUPPL-9（补充） Approval Labeling STANDARD
2018/02/15 SUPPL-8（补充） Approval Labeling STANDARD
2004/06/25 SUPPL-4（补充） Approval Labeling
1997/01/08 SUPPL-3（补充） Approval Manufacturing (CMC)
1997/01/08 SUPPL-2（补充） Approval Manufacturing (CMC)
1994/08/24 SUPPL-1（补充） Approval Labeling
1987/05/12 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 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 STERISCIENCE
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 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 STERISCIENCE
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 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 STERISCIENCE
090583 003 ANDA AMPICILLIN SODIUM AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 500MG 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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