LIDOCAINE HYDROCHLORIDE 0.2% IN 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	LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	200MG/100ML	No	No	None	1980/12/19	Approved Prior to Jan 1, 1982	Discontinued
002	LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	400MG/100ML	No	No	None	Approved Prior to Jan 1, 1982	Discontinued
003	LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	800MG/100ML	No	No	None	1982/11/05	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
1980/12/19	ORIG-1（原始申请）	Approval	Type 4 - New Combination	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	通知信、审评文件、说明书、包装标签
2014/05/09	SUPPL-86（补充）	Approval	Manufacturing (CMC)	STANDARD
2014/04/07	SUPPL-85（补充）	Approval	Manufacturing (CMC)	STANDARD
2014/01/15	SUPPL-84（补充）	Approval	Labeling-Package Insert	STANDARD	Label Letter
1999/08/26	SUPPL-67（补充）	Approval	Labeling	STANDARD
1999/08/26	SUPPL-64（补充）	Approval	Labeling	STANDARD
1998/11/05	SUPPL-66（补充）	Approval	Manufacturing (CMC)	STANDARD
1997/06/12	SUPPL-65（补充）	Approval	Manufacturing (CMC)	STANDARD
1997/03/18	SUPPL-63（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1996/07/17	SUPPL-59（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1996/07/09	SUPPL-62（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1996/06/26	SUPPL-58（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1996/02/02	SUPPL-61（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1995/08/17	SUPPL-56（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1995/08/03	SUPPL-60（补充）	Approval	Manufacturing (CMC)	STANDARD
1993/11/03	SUPPL-55（补充）	Approval	Labeling	STANDARD
1992/05/01	SUPPL-48（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1992/01/28	SUPPL-53（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1991/09/10	SUPPL-52（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1991/08/30	SUPPL-54（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1990/02/22	SUPPL-49（补充）	Approval	Manufacturing (CMC)	STANDARD
1990/01/11	SUPPL-50（补充）	Approval	Manufacturing (CMC)	STANDARD
1989/09/13	SUPPL-27（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1986/12/15	SUPPL-41（补充）	Approval	Manufacturing (CMC)-Expiration Date	STANDARD
1986/11/26	SUPPL-45（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1986/08/08	SUPPL-44（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1986/01/31	SUPPL-40（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1985/11/01	SUPPL-38（补充）	Approval	Labeling
1985/11/01	SUPPL-33（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1985/10/29	SUPPL-29（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1985/10/26	SUPPL-39（补充）	Approval	Labeling
1985/10/26	SUPPL-36（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1985/09/26	SUPPL-31（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1985/06/10	SUPPL-43（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1985/05/10	SUPPL-42（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1985/05/03	SUPPL-37（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1984/11/28	SUPPL-28（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1984/10/22	SUPPL-32（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1984/10/17	SUPPL-25（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1984/10/10	SUPPL-18（补充）	Approval	Labeling
1984/10/10	SUPPL-17（补充）	Approval	Manufacturing (CMC)-Packaging	STANDARD
1984/04/09	SUPPL-26（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1984/03/21	SUPPL-24（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1984/03/01	SUPPL-15（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1984/02/17	SUPPL-19（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1983/12/08	SUPPL-20（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1983/09/06	SUPPL-23（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1983/06/16	SUPPL-21（补充）	Approval	Labeling
1983/02/15	SUPPL-14（补充）	Approval	Manufacturing (CMC)	STANDARD
1982/11/05	SUPPL-12（补充）	Approval	Labeling
1982/11/05	SUPPL-11（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1982/07/26	SUPPL-16（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1982/07/08	SUPPL-13（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1982/06/09	SUPPL-7（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1982/02/01	SUPPL-10（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1982/01/08	SUPPL-9（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1981/10/01	SUPPL-6（补充）	Approval	Labeling
1981/05/16	SUPPL-2（补充）	Approval	Manufacturing (CMC)-Control	STANDARD
1981/04/22	SUPPL-3（补充）	Approval	Labeling
1981/04/21	SUPPL-5（补充）	Approval	Labeling
1981/04/21	SUPPL-4（补充）	Approval	Manufacturing (CMC)-Control	STANDARD