药品名称DDAVP (NEEDS NO REFRIGERATION)
申请号017922产品号003
活性成分DESMOPRESSIN ACETATE市场状态处方药
剂型或给药途径SPRAY, METERED;NASAL规格0.01MG/SPRAY
治疗等效代码AB参比药物
批准日期1996/08/07申请机构FERRING PHARMACEUTICALS INC
化学类型New molecular entity (NME)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
54829312013/06/29PDF格式
55004132013/06/29PDF格式
56748502013/12/23PDF格式
57634072013/06/29PDF格式
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
017922042APLetter2015/11/09下载
017922042APLabel2015/11/19下载
017922038APLabel2007/11/07下载
017922038APLetter2007/11/08下载
017922034APLabel2005/11/16下载
017922034APLetter2005/11/17下载
017922031APLetter2003/11/25下载
017922000APOther Important Information from FDA2007/12/04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
017922044AP2015/07/31Manufacturing Change or Addition
017922043AP2014/02/28Manufacturing Change or Addition
017922042AP2015/11/05Labeling Revision
017922039AP2007/10/26Labeling Revision
017922038AP2007/10/26Labeling Revision
017922034AP2005/11/10Labeling Revision
017922031AP2003/11/12Labeling Revision
017922029AP2001/02/28Control Supplement
017922028AP2000/10/31Control Supplement
017922027AP2000/07/05Control Supplement
017922026AP1999/09/24Control Supplement
017922025AP1998/04/13Labeling Revision
017922024AP1996/01/16Labeling Revision
017922023AP1996/08/07Formulation Revision
017922022AP1995/01/26Control Supplement
017922021AP1991/09/27Labeling Revision
017922020AP1992/04/22Manufacturing Change or Addition
017922019AP1990/08/23Labeling Revision
017922018AP1989/07/19Labeling Revision
017922017AP1989/06/23Package Change
017922015AP1988/05/25Manufacturing Change or Addition
017922014AP1988/06/29Control Supplement
017922013AP1989/02/06Package Change
017922012AP1989/11/28New or Modified Indication
017922011AP1985/11/07Labeling Revision
017922010AP1984/11/27Labeling Revision
017922009AP1984/06/01Package Change
017922007AP1983/01/21Labeling Revision
017922006AP1983/03/24Labeling Revision
017922005AP1982/08/27Control Supplement
017922004AP1982/06/08Labeling Revision
017922002AP1981/05/21Package Change
017922001AP1980/02/28Manufacturing Change or Addition
017922000AP1978/02/21Approval