PLASMA-LYTE M AND DEXTROSE 5% 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	PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER	CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM LACTATE	INJECTABLE;INJECTION	37MG/100ML;5GM/100ML;30MG/100ML;119MG/100ML;161MG/100ML;94MG/100ML;138MG/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None	1979/02/01	Approved Prior to Jan 1, 1982	Discontinued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
1979/02/01	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
2001/08/14	SUPPL-55（补充）	Approval	Manufacturing (CMC)	STANDARD
2001/02/01	SUPPL-54（补充）	Approval	Labeling	STANDARD
2000/11/29	SUPPL-52（补充）	Approval	Labeling	STANDARD
1999/11/24	SUPPL-53（补充）	Approval	Manufacturing (CMC)	STANDARD
1997/04/29	SUPPL-51（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1994/09/30	SUPPL-49（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1994/02/18	SUPPL-50（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1991/04/29	SUPPL-46（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1991/04/26	SUPPL-47（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1991/03/26	SUPPL-45（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1991/02/15	SUPPL-44（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1989/07/26	SUPPL-43（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1987/07/25	SUPPL-42（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1987/05/28	SUPPL-41（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1986/02/27	SUPPL-39（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1985/08/28	SUPPL-31（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1985/08/28	SUPPL-30（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1985/06/13	SUPPL-35（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1985/04/18	SUPPL-36（补充）	Approval	Labeling	STANDARD
1985/04/15	SUPPL-38（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1985/01/24	SUPPL-28（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1984/09/22	SUPPL-34（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1984/03/16	SUPPL-29（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1984/02/28	SUPPL-33（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1983/07/11	SUPPL-25（补充）	Approval	Labeling	STANDARD
1982/06/03	SUPPL-22（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1982/04/16	SUPPL-21（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1982/02/16	SUPPL-26（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1981/12/21	SUPPL-19（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1981/11/20	SUPPL-24（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1981/08/26	SUPPL-20（补充）	Approval	Labeling	STANDARD
1981/06/29	SUPPL-17（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1981/04/16	SUPPL-12（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1981/01/21	SUPPL-16（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1980/08/07	SUPPL-5（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1980/08/06	SUPPL-13（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1980/07/31	SUPPL-14（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1980/06/28	SUPPL-2（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1980/06/18	SUPPL-9（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1980/05/30	SUPPL-11（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1980/02/25	SUPPL-1（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1980/01/15	SUPPL-7（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1979/08/10	SUPPL-6（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1979/08/02	SUPPL-4（补充）	Approval	Manufacturing (CMC)-Control	STANDARD