药品注册申请号:050750
申请类型:NDA (新药申请)
申请人:WYETH PHARMS
申请人全名:WYETH PHARMACEUTICALS LLC
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 ZOSYN IN PLASTIC CONTAINER PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 40MG BASE/ML;EQ 5MG BASE/ML Yes Yes None 1998/02/24 1998/02/24 Prescription
002 ZOSYN IN PLASTIC CONTAINER PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 60MG BASE/ML;EQ 7.5MG BASE/ML Yes Yes None 1998/02/24 Prescription
003 ZOSYN IN PLASTIC CONTAINER PIPERACILLIN SODIUM; TAZOBACTAM SODIUM INJECTABLE;INJECTION EQ 4GM BASE/100ML;EQ 500MG BASE/100ML Yes Yes None 1998/02/24 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2019/05/10 SUPPL 41 Approval Labeling STANDARD
2017/05/05 SUPPL 39 Approval Labeling STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2017/05/05 SUPPL 38 Approval Labeling STANDARD
2017/05/05 SUPPL 37 Approval Labeling STANDARD
2016/06/10 SUPPL 35 Approval Labeling STANDARD
2016/06/10 SUPPL 34 Approval Labeling STANDARD
2015/12/18 SUPPL 33 Approval Labeling STANDARD
2014/07/17 SUPPL 31 Approval Manufacturing (CMC) STANDARD
2014/06/24 SUPPL 32 Approval Manufacturing (CMC) STANDARD
2013/09/06 SUPPL 30 Approval Labeling STANDARD
2013/09/06 SUPPL 26 Approval Labeling STANDARD
2013/09/06 SUPPL 21 Approval Labeling STANDARD
2013/06/18 SUPPL 28 Approval Manufacturing (CMC) STANDARD
2012/05/11 SUPPL 20 Approval Labeling STANDARD
2012/05/11 SUPPL 16 Approval Labeling STANDARD
2011/09/28 SUPPL 24 Approval Labeling STANDARD
2008/04/17 SUPPL 15 Approval Labeling STANDARD
2006/07/26 SUPPL 14 Approval Efficacy STANDARD
2005/09/30 SUPPL 12 Approval Manufacturing (CMC) STANDARD
2005/06/27 SUPPL 11 Approval Labeling STANDARD
2005/03/15 SUPPL 9 Approval Labeling STANDARD
2003/05/06 SUPPL 8 Approval Efficacy STANDARD
2003/05/06 SUPPL 7 Approval Labeling STANDARD
2002/03/27 SUPPL 3 Approval Labeling STANDARD
2002/03/14 SUPPL 5 Approval Manufacturing (CMC) STANDARD
2001/02/01 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1998/07/13 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1998/02/24 ORIG 1 Approval Type 3 - New Dosage Form 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
001 6207661 2019/02/22 Y PDF格式
6900184 2023/04/14 Y U-282 PDF格式
7915229 2023/04/14 Y 2011/04/22 PDF格式
8133883 2023/04/14 Y U-282 2012/04/11 PDF格式
002 6207661 2019/02/22 Y PDF格式
6900184 2023/04/14 Y U-282 PDF格式
7915229 2023/04/14 Y PDF格式
8133883 2023/04/14 Y U-282 PDF格式
003 6207661 2019/02/22 Y PDF格式
6900184 2023/04/14 Y U-282 PDF格式
7915229 2023/04/14 Y PDF格式
8133883 2023/04/14 Y U-282 PDF格式
001 6207661 2019/02/22 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
6900184 2023/04/14 Y Y U-282 PDF格式**本条是由Drugfuture回溯的历史信息**
002 6207661 2019/02/22 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
6900184 2023/04/14 Y Y U-282 PDF格式**本条是由Drugfuture回溯的历史信息**
003 6207661 2019/02/22 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
6900184 2023/04/14 Y Y U-282 PDF格式**本条是由Drugfuture回溯的历史信息**
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
本品无治疗等效药品
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药品NDC数据与药品包装、标签说明书
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