LEUCOVORIN CALCIUM-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	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	INJECTABLE;INJECTION	EQ 3MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None	1952/06/20	Approved Prior to Jan 1, 1982	Discontinued
002	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	INJECTABLE;INJECTION	EQ 50MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		Approved Prior to Jan 1, 1982	Discontinued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	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	FOR SOLUTION;ORAL	EQ 60MG BASE/VIAL	No	No	None		1987/01/30	Discontinued
004	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	INJECTABLE;INJECTION	EQ 100MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		1988/05/23	Discontinued
005	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM	INJECTABLE;INJECTION	EQ 350MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	None		1989/04/05	Discontinued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

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
2003/12/17	SUPPL-55（补充）	Approval	Manufacturing (CMC)	PRIORITY	Letter
2002/02/12	SUPPL-54（补充）	Approval	Labeling	STANDARD	Review Letter
1999/11/08	SUPPL-52（补充）	Approval	Manufacturing (CMC)	PRIORITY
1997/07/21	SUPPL-51（补充）	Approval	Labeling	STANDARD
1996/05/24	SUPPL-50（补充）	Approval	Labeling	STANDARD
1996/01/26	SUPPL-49（补充）	Approval	Manufacturing (CMC)	PRIORITY
1992/12/15	SUPPL-48（补充）	Approval	Labeling
1992/03/10	SUPPL-42（补充）	Approval	Manufacturing (CMC)	PRIORITY
1991/12/12	SUPPL-40（补充）	Approval	Efficacy
1990/09/11	SUPPL-46（补充）	Approval	Manufacturing (CMC)	PRIORITY
1989/08/23	SUPPL-43（补充）	Approval	Manufacturing (CMC)	PRIORITY
1989/04/05	SUPPL-38（补充）	Approval	Manufacturing (CMC)	PRIORITY
1988/08/31	SUPPL-39（补充）	Approval	Efficacy
1988/08/30	SUPPL-35（补充）	Approval	Labeling
1988/05/23	SUPPL-36（补充）	Approval	Manufacturing (CMC)	PRIORITY
1987/01/30	SUPPL-34（补充）	Approval	Labeling
1987/01/30	SUPPL-33（补充）	Approval	Efficacy
1987/01/30	SUPPL-32（补充）	Approval	Efficacy
1984/06/28	SUPPL-31（补充）	Approval	Manufacturing (CMC)	PRIORITY
1984/02/22	SUPPL-30（补充）	Approval	Manufacturing (CMC)	PRIORITY
1983/03/29	SUPPL-29（补充）	Approval	Labeling
1981/03/27	SUPPL-27（补充）	Approval	Labeling
1981/01/27	SUPPL-26（补充）	Approval	Manufacturing (CMC)	PRIORITY
1980/12/22	SUPPL-25（补充）	Approval	Manufacturing (CMC)	PRIORITY
1980/12/19	SUPPL-24（补充）	Approval	Manufacturing (CMC)	PRIORITY
1980/09/04	SUPPL-23（补充）	Approval	Manufacturing (CMC)	PRIORITY
1980/04/28	SUPPL-20（补充）	Approval	Manufacturing (CMC)	PRIORITY
1980/02/05	SUPPL-22（补充）	Approval	Manufacturing (CMC)	PRIORITY
1980/01/16	SUPPL-21（补充）	Approval	Manufacturing (CMC)	PRIORITY
1979/09/07	SUPPL-18（补充）	Approval	Manufacturing (CMC)	PRIORITY
1979/07/25	SUPPL-19（补充）	Approval	Manufacturing (CMC)	PRIORITY
1979/03/09	SUPPL-15（补充）	Approval	Manufacturing (CMC)	PRIORITY
1979/03/06	SUPPL-17（补充）	Approval	Manufacturing (CMC)	PRIORITY
1979/03/06	SUPPL-16（补充）	Approval	Manufacturing (CMC)	PRIORITY
1977/11/11	SUPPL-14（补充）	Approval	Manufacturing (CMC)	PRIORITY
1977/08/15	SUPPL-13（补充）	Approval	Manufacturing (CMC)	PRIORITY
1952/06/20	ORIG-1（原始申请）	Approval	Type 1 - New Molecular Entity	PRIORITY ;Orphan