药品名称FREAMINE III 8.5%
申请号016822产品号004
活性成分AMINO ACIDS市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格8.5% (8.5GM/100ML)
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构B BRAUN MEDICAL INC
化学类型New combination审评分类Priority 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
016822065APLabel2004/06/01下载
016822065APLetter2004/06/01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
016822081AP2013/11/08Manufacturing Change or Addition
016822077AP2013/01/09Manufacturing Change or Addition
016822075AP2013/03/15Manufacturing Change or Addition
016822074AP2013/03/19Manufacturing Change or Addition
016822072AP2014/03/12Manufacturing Change or Addition
016822065AP2004/05/27Control Supplement
016822064AP2000/06/20Control Supplement
016822063AP2000/04/12Control Supplement
016822062AP1999/05/04Control Supplement
016822061AP1996/06/14Control Supplement
016822060AP1995/09/13Control Supplement
016822059AP1994/10/28Manufacturing Change or Addition
016822058AP1993/06/08Control Supplement
016822057AP1992/09/28Manufacturing Change or Addition
016822056AP1991/12/11Manufacturing Change or Addition
016822055AP1990/04/11Control Supplement
016822052AP1988/01/13Labeling Revision
016822051AP1987/12/28Labeling Revision
016822050AP1987/07/09Labeling Revision
016822049AP1987/07/09Labeling Revision
016822048AP1986/10/08Labeling Revision
016822047AP1985/10/21Labeling Revision
016822046AP1985/10/21Labeling Revision
016822045AP1985/06/14Control Supplement
016822044AP1988/07/01Labeling Revision
016822043AP1988/07/01Control Supplement
016822042AP1984/09/08Labeling Revision
016822041AP1988/04/11Labeling Revision
016822040AP1988/04/11Package Change
016822039AP1985/10/15Labeling Revision
016822038AP1985/10/15Control Supplement
016822037AP1985/07/23Labeling Revision
016822036AP1985/07/23Control Supplement
016822035AP1982/06/29Formulation Revision
016822034AP1982/08/26Control Supplement
016822033AP1983/05/17Labeling Revision
016822032AP1983/05/17Control Supplement
016822031AP1982/05/03Control Supplement
016822030AP1983/04/25Practioner Draft Labeling
016822029AP1982/06/17Control Supplement
016822028AP1981/05/04Control Supplement
016822027AP1981/04/10Control Supplement
016822026AP1981/06/20Labeling Revision
016822025AP1981/06/20Control Supplement
016822024AP1980/11/07Control Supplement
016822023AP1980/12/09Control Supplement
016822022AP1980/06/25Expiration Date Change
016822021AP1980/08/07Labeling Revision
016822020AP1980/08/07Control Supplement
016822019AP1980/08/20Control Supplement
016822018AP1980/06/06Control Supplement
016822017AP1980/04/20Control Supplement
016822016AP1980/04/17Labeling Revision
016822015AP1980/04/17Control Supplement
016822013AP1978/08/18Labeling Revision
016822012AP1978/10/02Labeling Revision
016822011AP1978/10/02Control Supplement
016822010AP1977/07/19Control Supplement
016822009AP1977/09/01Control Supplement
016822007AP1977/05/26General Efficacy (MarkIV)
016822006AP1977/05/06Labeling Revision
016822005AP1975/01/23Control Supplement
016822000AP1971/09/24Approval