XYLOCAINE PRESERVATIVE FREE-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	XYLOCAINE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None	1969/10/06	Approved Prior to Jan 1, 1982	Discontinued
002	XYLOCAINE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued
003	XYLOCAINE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	10% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	No	No	None		Approved Prior to Jan 1, 1982	Discontinued
004	XYLOCAINE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	20% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued
005	XYLOCAINE PRESERVATIVE FREE	LIDOCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		1988/01/19	Discontinued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
2013/04/18	SUPPL-42（补充）	Approval	Manufacturing (CMC)	STANDARD
2013/03/28	SUPPL-41（补充）	Approval	Labeling	STANDARD
2000/12/08	SUPPL-35（补充）	Approval	Manufacturing (CMC)	STANDARD
1997/02/20	SUPPL-34（补充）	Approval	Manufacturing (CMC)	STANDARD
1997/02/04	SUPPL-33（补充）	Approval	Labeling	STANDARD
1995/05/31	SUPPL-32（补充）	Approval	Manufacturing (CMC)	STANDARD
1994/07/15	SUPPL-31（补充）	Approval	Manufacturing (CMC)	STANDARD
1993/02/18	SUPPL-30（补充）	Approval	Manufacturing (CMC)	STANDARD
1989/07/11	SUPPL-29（补充）	Approval	Manufacturing (CMC)	STANDARD
1988/08/26	SUPPL-28（补充）	Approval	Labeling
1988/01/19	SUPPL-27（补充）	Approval	Labeling
1987/09/16	SUPPL-26（补充）	Approval	Manufacturing (CMC)	STANDARD
1986/09/04	SUPPL-25（补充）	Approval	Labeling
1986/09/04	SUPPL-24（补充）	Approval	Manufacturing (CMC)	STANDARD
1986/04/03	SUPPL-23（补充）	Approval	Manufacturing (CMC)	STANDARD
1983/09/02	SUPPL-22（补充）	Approval	Labeling
1983/04/27	SUPPL-18（补充）	Approval	Labeling
1982/07/22	SUPPL-17（补充）	Approval	Labeling
1982/07/22	SUPPL-16（补充）	Approval	Manufacturing (CMC)	STANDARD
1982/07/08	SUPPL-21（补充）	Approval	Manufacturing (CMC)	STANDARD
1982/03/25	SUPPL-20（补充）	Approval	Manufacturing (CMC)	STANDARD
1982/02/22	SUPPL-19（补充）	Approval	Labeling
1980/12/15	SUPPL-15（补充）	Approval	Labeling
1979/12/28	SUPPL-11（补充）	Approval	Manufacturing (CMC)	STANDARD
1979/12/07	SUPPL-14（补充）	Approval	Labeling
1979/12/07	SUPPL-13（补充）	Approval	Manufacturing (CMC)	STANDARD
1978/10/12	SUPPL-10（补充）	Approval	Manufacturing (CMC)	STANDARD
1978/09/29	SUPPL-9（补充）	Approval	Labeling
1978/09/29	SUPPL-8（补充）	Approval	Manufacturing (CMC)	STANDARD
1976/05/27	SUPPL-7（补充）	Approval	Labeling
1976/04/15	SUPPL-6（补充）	Approval	Manufacturing (CMC)	STANDARD
1975/02/12	SUPPL-4（补充）	Approval	Labeling
1969/10/06	ORIG-1（原始申请）	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD