药品名称BACTRIM PEDIATRIC
申请号017560产品号002
活性成分SULFAMETHOXAZOLE; TRIMETHOPRIM市场状态停止上市
剂型或给药途径SUSPENSION;ORAL规格200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构SUN PHARMACEUTICAL INDUSTRIES INC
化学类型New dosage form审评分类Standard review drug
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历史专利信息
与本品相关的市场独占权保护信息
独占权代码失效日期
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与药品注册相关的信息
申请号修订号审批结论公开文档类型文档创建时间获取文档
药品注册审批历史信息
申请号修订号审批结论审批日期审批内容
017560043AP2001/11/09Control Supplement
017560039AP1990/06/15New or Modified Indication
017560036AP1987/06/04Control Supplement
017560035AP1996/03/06Labeling Revision
017560034AP1987/08/11Labeling Revision
017560033AP1985/06/10Control Supplement
017560032AP1985/02/20Control Supplement
017560031AP1984/06/12Control Supplement
017560030AP1984/11/23Labeling Revision
017560028AP1982/06/15Control Supplement
017560027AP1982/03/29Package Change
017560026AP1981/10/09Control Supplement
017560025AP1981/04/23Control Supplement
017560024AP1981/01/09Control Supplement
017560023AP1981/01/09Control Supplement
017560022AP1981/01/09Control Supplement
017560021AP1980/10/28Control Supplement
017560020AP1980/12/10Expiration Date Change
017560019AP1980/10/31Labeling Revision
017560018AP1982/02/23General Efficacy (MarkIV)
017560017AP1979/12/17Package Change
017560016AP1979/12/17Labeling Revision
017560015AP1979/12/07Control Supplement
017560014AP1979/12/17Labeling Revision
017560013AP1979/12/07Manufacturing Change or Addition
017560012AP1979/07/26Labeling Revision
017560011AP1979/02/27Formulation Revision
017560010AP1977/11/14Labeling Revision
017560009AP1977/04/21Package Change
017560008AP1978/10/11Labeling Revision
017560007AP1978/03/01Labeling Revision
017560006AP1976/08/23Packaging Addition
017560005AP1976/12/27Control Supplement
017560003AP1976/06/01Labeling Revision
017560000AP1975/04/15Approval