PHYSIOSOL IN PLASTIC CONTAINER-美国FDA药品数据库-药物在线

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	PHYSIOSOL IN PLASTIC CONTAINER	MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE	SOLUTION;IRRIGATION	14MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML	No	No	None	1980/08/25	Approved Prior to Jan 1, 1982	Discontinued
002	PHYSIOSOL PH 7.4 IN PLASTIC CONTAINER	MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE	SOLUTION;IRRIGATION	30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML	No	No	None	1982/07/08	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

>>>原始批准或临时批准<<<

审批日期	提交号	审批结论	提交分类	审评优先级；罕用药状态	通知信、审评文件、说明书、包装标签	备注
1980/08/25	ORIG-1（原始申请）	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD

>>>补充申请<<<

审批日期	提交号	审批结论	补充类别或审批类型	审评优先级；罕用药状态
2000/02/23	SUPPL-51（补充）	Approval	Labeling	STANDARD
1997/11/19	SUPPL-48（补充）	Approval	Labeling	STANDARD
1997/08/21	SUPPL-50（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1997/06/11	SUPPL-49（补充）	Approval	Manufacturing (CMC)	STANDARD
1997/03/28	SUPPL-47（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1996/10/22	SUPPL-46（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1996/08/29	SUPPL-45（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1996/08/27	SUPPL-44（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1995/08/14	SUPPL-42（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1992/01/28	SUPPL-38（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1991/09/10	SUPPL-37（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1991/08/30	SUPPL-39（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1990/02/22	SUPPL-34（补充）	Approval	Manufacturing (CMC)	STANDARD
1990/01/11	SUPPL-35（补充）	Approval	Manufacturing (CMC)	STANDARD
1989/09/13	SUPPL-16（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1988/10/17	SUPPL-33（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1987/07/30	SUPPL-30（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1986/11/26	SUPPL-29（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1986/10/31	SUPPL-26（补充）	Approval	Labeling
1986/10/31	SUPPL-25（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1986/08/08	SUPPL-28（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1986/02/21	SUPPL-27（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1986/01/31	SUPPL-24（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1986/01/31	SUPPL-23（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1985/10/29	SUPPL-17（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1985/09/26	SUPPL-19（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1985/05/14	SUPPL-22（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1984/11/09	SUPPL-21（补充）	Approval	Manufacturing (CMC)	STANDARD
1984/10/22	SUPPL-20（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1984/10/17	SUPPL-15（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1984/09/22	SUPPL-12（补充）	Approval	Labeling
1984/09/22	SUPPL-11（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1984/03/21	SUPPL-14（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1984/03/01	SUPPL-13（补充）	Approval	Manufacturing (CMC)	STANDARD
1984/03/01	SUPPL-9（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1982/07/26	SUPPL-10（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1982/07/08	SUPPL-2（补充）	Approval	Labeling
1982/06/18	SUPPL-8（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1982/06/09	SUPPL-5（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1982/02/01	SUPPL-7（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1982/01/08	SUPPL-6（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1981/09/16	SUPPL-3（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1981/04/29	SUPPL-4（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1981/01/19	SUPPL-1（补充）	Approval	Manufacturing (CMC)-Control	STANDARD