THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER-美国FDA药品数据库-药物在线

产品信息

产品号	商品名	活性成分	剂型/给药途径	规格/剂量	参比药物(RLD)	生物等效参考标准(RS)	治疗等效代码	该申请号批准日期	该产品号批准日期	市场状态
001	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE	INJECTABLE;INJECTION	40MG/100ML	Yes	No	None	1984/12/14	1984/12/14	Discontinued
002	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE	INJECTABLE;INJECTION	80MG/100ML	No	No	None		1984/12/14	Discontinued
003	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE	INJECTABLE;INJECTION	160MG/100ML	Yes	No	None		1984/12/14	Discontinued
004	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE	INJECTABLE;INJECTION	200MG/100ML	No	No	None		1984/12/14	Discontinued
005	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE	INJECTABLE;INJECTION	400MG/100ML	No	No	None		1984/12/14	Discontinued
006	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE	INJECTABLE;INJECTION	320MG/100ML	Yes	No	None		1988/01/20	Discontinued
007	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE	INJECTABLE;INJECTION	4MG/ML	Yes	No	None		1984/12/14	Discontinued

批准日期，申请提交历史，通知信，药品说明书，审评文件等信息

提交状态日期	提交号	审批结论	申请内容分类	审评优先级；罕用药状态	通知信、审评文件、说明书、包装标签
2009/03/26	SUPPL-42（补充）	Approval	Labeling	STANDARD	Letter Label
2008/10/31	SUPPL-40（补充）	Approval	Labeling	STANDARD	Letter Label
2002/11/01	SUPPL-30（补充）	Approval	Manufacturing (CMC)	STANDARD
1998/11/10	SUPPL-28（补充）	Approval	Manufacturing (CMC)	STANDARD
1997/07/10	SUPPL-27（补充）	Approval	Manufacturing (CMC)	STANDARD
1996/07/22	SUPPL-26（补充）	Approval	Manufacturing (CMC)	STANDARD
1996/07/09	SUPPL-20（补充）	Approval	Manufacturing (CMC)	STANDARD
1996/07/09	SUPPL-19（补充）	Approval	Manufacturing (CMC)	STANDARD
1996/02/13	SUPPL-24（补充）	Approval	Manufacturing (CMC)	STANDARD
1996/02/05	SUPPL-25（补充）	Approval	Labeling	STANDARD
1996/02/02	SUPPL-18（补充）	Approval	Labeling	STANDARD
1995/08/21	SUPPL-22（补充）	Approval	Manufacturing (CMC)	STANDARD
1992/07/13	SUPPL-16（补充）	Approval	Manufacturing (CMC)	STANDARD
1992/03/23	SUPPL-14（补充）	Approval	Manufacturing (CMC)	STANDARD
1992/03/23	SUPPL-7（补充）	Approval	Manufacturing (CMC)	STANDARD
1991/12/02	SUPPL-15（补充）	Approval	Manufacturing (CMC)	STANDARD
1990/02/22	SUPPL-13（补充）	Approval	Manufacturing (CMC)	STANDARD
1988/01/20	SUPPL-11（补充）	Approval	Labeling
1988/01/20	SUPPL-10（补充）	Approval	Manufacturing (CMC)	STANDARD
1986/11/26	SUPPL-6（补充）	Approval	Manufacturing (CMC)	STANDARD
1986/10/31	SUPPL-8（补充）	Approval	Labeling
1986/08/29	SUPPL-2（补充）	Approval	Manufacturing (CMC)	STANDARD
1986/08/11	SUPPL-5（补充）	Approval	Manufacturing (CMC)	STANDARD
1986/08/08	SUPPL-4（补充）	Approval	Manufacturing (CMC)	STANDARD
1986/01/31	SUPPL-1（补充）	Approval	Manufacturing (CMC)	STANDARD
1986/01/24	SUPPL-3（补充）	Approval	Manufacturing (CMC)	STANDARD
1984/12/14	ORIG-1（原始申请）	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD