药品名称PITOCIN
申请号018261产品号003
活性成分OXYTOCIN市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格500USP UNITS/50ML (10USP UNITS/ML)
治疗等效代码参比药物
批准日期2012/09/05申请机构PAR STERILE PRODUCTS LLC
化学类型New formulation or new manufacturer审评分类Standard review drug
与本品相关的专利信息(来自橙皮书Orange Book)
专利号专利过期日是否化合物专利是否产品专利专利用途代码专利下载
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
历史市场独占权保护信息
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
018261031APLetter2014/10/03下载
018261031APLabel2014/10/03下载
018261028APLabel2007/07/30下载
018261028APLetter2007/07/31下载
018261023APLetter2003/03/26下载
018261023APReview2008/04/04下载
018261021APReview2008/04/04下载
018261021APLetter2002/01/10下载
018261011APReview1997/07/29下载
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
018261034AP2016/08/19Manufacturing Change or Addition
018261033AP2016/08/15Manufacturing Change or Addition
018261032AP2014/06/18Manufacturing Change or Addition
018261031AP2014/10/02Labeling Revision
018261028AP2007/07/27Package Change
018261023AP2003/03/24Labeling Revision
018261022AP2001/09/24Control Supplement
018261021AP2002/01/10Labeling Revision
018261020AP2001/03/08Labeling Revision
018261019AP2001/03/08Expiration Date Change
018261018AP2001/03/08Control Supplement
018261017AP2000/10/25Control Supplement
018261016AP2000/03/23Package Change
018261015AP2000/03/01Expiration Date Change
018261014AP1999/11/10Control Supplement
018261013AP1999/02/22Labeling Revision
018261012AP1997/07/10Control Supplement
018261011AP1997/07/29Labeling Revision
018261009AP1996/02/22Labeling Revision
018261008AP1994/05/27Control Supplement
018261007AP1994/08/23Labeling Revision
018261006AP1994/08/09Labeling Revision
018261005AP1990/07/03Labeling Revision
018261004AP1988/02/16Labeling Revision
018261003AP1987/01/29Control Supplement
018261002AP1986/09/19Labeling Revision
018261001AP1984/01/27Control Supplement
018261000AP1980/11/19Approval