药品名称DEXTROSE 5% IN PLASTIC CONTAINER
申请号016367产品号002
活性成分DEXTROSE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格50MG/ML
治疗等效代码AP参比药物
批准日期Approved Prior to Jan 1, 1982申请机构HOSPIRA INC
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
016367182APLabel2006/10/27下载
016367182APLetter2006/10/31下载
016367178APLabel2005/09/07下载
016367178APLetter2005/09/07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
016367220AP2016/02/23Manufacturing Change or Addition
016367218AP2013/09/05Manufacturing Change or Addition
016367182AP2006/10/26Package Change
016367178AP2005/09/02Package Change
016367174AP2002/11/08Control Supplement
016367173AP2002/04/03Manufacturing Change or Addition
016367172AP2002/04/03Manufacturing Change or Addition
016367171AP2000/03/03Package Change
016367170AP2000/03/06Labeling Revision
016367169AP1999/06/04Control Supplement
016367168AP1998/10/29Control Supplement
016367167AP1997/08/21Package Change
016367166AP1997/06/11Manufacturing Change or Addition
016367165AP1997/08/20Labeling Revision
016367164AP1997/03/28Control Supplement
016367163AP1996/08/06Control Supplement
016367162AP1996/03/04Control Supplement
016367161AP1995/08/18Manufacturing Change or Addition
016367160AP1996/08/29Control Supplement
016367159AP1996/08/27Control Supplement
016367157AP1995/08/14Control Supplement
016367156AP1994/05/24Labeling Revision
016367153AP1991/08/30Package Change
016367152AP1992/01/28Package Change
016367151AP1991/09/10Control Supplement
016367149AP1990/01/11Manufacturing Change or Addition
016367148AP1990/02/22Manufacturing Change or Addition
016367147AP1989/06/14Control Supplement
016367146AP1988/08/08Manufacturing Change or Addition
016367145AP1988/10/17Expiration Date Change
016367142AP1987/07/30Control Supplement
016367141AP1986/11/26Control Supplement
016367140AP1986/08/08Control Supplement
016367139AP1986/02/21Control Supplement
016367138AP1986/01/18Control Supplement
016367135AP1985/06/21Control Supplement
016367134AP1985/06/10Control Supplement
016367133AP1985/11/07Labeling Revision
016367132AP1985/09/30Expiration Date Change
016367130AP1985/08/27Expiration Date Change
016367125AP1985/10/26Labeling Revision
016367122AP1985/05/03Control Supplement
016367121AP1985/10/26Control Supplement
016367120AP1985/01/18Labeling Revision
016367119AP1985/01/18Control Supplement
016367116AP1984/10/22Control Supplement
016367115AP1985/09/26Package Change
016367111AP1985/11/29Labeling Revision
016367110AP1985/11/29Control Supplement
016367109AP1985/10/29Package Change
016367108AP1984/11/28Control Supplement
016367107AP1988/08/31Control Supplement
016367106AP1985/01/08Labeling Revision
016367105AP1985/01/08Control Supplement
016367104AP1984/04/09Control Supplement
016367103AP1984/06/14Expiration Date Change
016367102AP1984/09/25Control Supplement
016367101AP1984/10/17Control Supplement
016367100AP1984/03/21Control Supplement
016367099AP1983/08/31Control Supplement
016367098AP1983/01/17Expiration Date Change
016367097AP1983/12/08Control Supplement
016367096AP1983/09/19Manufacturing Change or Addition
016367095AP1984/02/17Control Supplement
016367094AP1983/06/06Manufacturing Change or Addition
016367093AP1983/01/25Control Supplement
016367092AP1984/10/10Labeling Revision
016367091AP1984/10/10Package Change
016367090AP1982/07/26Control Supplement
016367089AP1984/03/01Control Supplement
016367088AP1983/02/15Manufacturing Change or Addition
016367087AP1982/07/08Control Supplement
016367086AP1982/02/22Labeling Revision
016367085AP1982/02/01Control Supplement
016367084AP1982/01/08Control Supplement
016367083AP1982/06/09Control Supplement
016367082AP1981/10/07Control Supplement
016367081AP1981/10/21Labeling Revision
016367080AP1981/10/21Control Supplement
016367079AP1981/09/16Control Supplement
016367078AP1981/07/31Labeling Revision
016367077AP1981/07/31Control Supplement
016367076AP1981/03/02Labeling Revision
016367075AP1982/07/08Practioner Draft Labeling
016367074AP1981/03/02Labeling Revision
016367073AP1981/03/02Control Supplement
016367072AP1981/01/07Control Supplement
016367071AP1980/09/15Control Supplement
016367069AP1981/07/16Control Supplement
016367068AP1980/04/08Labeling Revision
016367067AP1979/10/10Control Supplement
016367066AP1979/11/29Control Supplement
016367065AP1980/07/14Expiration Date Change
016367064AP1980/01/22Control Supplement
016367063AP1980/04/16Labeling Revision
016367062AP1980/04/16Control Supplement
016367061AP1979/12/03Control Supplement
016367060AP1979/11/27Control Supplement
016367059AP1979/12/03Control Supplement
016367058AP1979/07/17Labeling Revision
016367057AP1979/02/01Supplement
016367056AP1978/11/01Control Supplement
016367055AP1978/10/17Labeling Revision
016367054AP1979/02/16Control Supplement
016367053AP1978/01/17Labeling Revision
016367052AP1978/01/17Control Supplement
016367051AP1979/03/27Labeling Revision
016367050AP1979/03/27Control Supplement
016367049AP1978/09/08Control Supplement
016367048AP1978/11/24Control Supplement
016367047AP1979/03/27Labeling Revision
016367046AP1979/03/27Control Supplement
016367045AP1979/02/06Control Supplement
016367044AP1978/09/08Control Supplement
016367043AP1978/08/15Control Supplement
016367042AP1978/09/08Control Supplement
016367040AP1978/06/26Control Supplement
016367039AP1978/02/08Labeling Revision
016367038AP1978/06/05Labeling Revision
016367037AP1978/06/05Control Supplement
016367036AP1978/08/03Control Supplement
016367035AP1978/04/06Labeling Revision
016367034AP1978/09/13Control Supplement
016367033AP1978/05/31Formulation Revision
016367032AP1978/02/17Labeling Revision
016367031AP1978/06/05Control Supplement
016367028AP1978/02/13Manufacturing Change or Addition
016367027AP1977/09/28Labeling Revision
016367026AP1977/09/28Labeling Revision
016367025AP1978/07/11Control Supplement
016367024AP1978/01/23Control Supplement
016367023AP1977/09/09Control Supplement
016367022AP1977/09/09Control Supplement
016367021AP1977/09/09Labeling Revision
016367020AP1977/09/09Labeling Revision
016367019AP1978/03/15Package Change
016367018AP1978/02/09Control Supplement
016367017AP1977/04/29Manufacturing Change or Addition
016367016AP1976/10/15Labeling Revision
016367015AP1976/11/23Control Supplement
016367013AP1976/03/01Labeling Revision
016367012AP1976/11/08Package Change
016367011AP1975/11/20Control Supplement
016367010AP1976/04/06Labeling Revision
016367009AP1976/04/06Control Supplement
016367008AP1975/09/03Control Supplement
016367007AP1975/10/29Control Supplement
016367006AP1975/05/20Control Supplement
016367002AP1975/05/20Control Supplement
016367000AP1971/02/12Approval