药品注册申请号：008107
申请类型：NDA (新药申请)
申请人：HOSPIRA
申请人全名：HOSPIRA INC
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 SOLUTION;INTRAMUSCULAR, INTRAVENOUS EQ 3MG BASE/ML (EQ 3MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1952/06/20 Approved Prior to Jan 1, 1982 Discontinued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CALCIUM INJECTABLE;INJECTION EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued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CALCIUM INJECTABLE;INJECTION EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1988/05/23 Discontinued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CALCIUM INJECTABLE;INJECTION EQ 350MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1989/04/05 Discontinued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、包装标签备注
2003/12/17 SUPPL-55（补充） Approval Manufacturing (CMC) PRIORITY
2002/02/12 SUPPL-54（补充） Approval Labeling STANDARD
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
与本品相关的专利信息（来自FDA橙皮书Orange Book）
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
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与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
无
与本品治疗等效的药品
本品无治疗等效药品
更多信息
药品NDC数据与药品包装、标签说明书
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