药品注册申请号:018654
申请类型:NDA (新药申请)
申请人:HLR
申请人全名:HLR TECHNOLOGY
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 VERSED MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1985/12/20 1985/12/20 Discontinued
002 VERSED MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1987/05/26 Discontinued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
2001/09/04 SUPPL-38(补充) Approval Labeling STANDARD
1999/12/20 SUPPL-37(补充) Approval Manufacturing (CMC) STANDARD
1999/02/19 SUPPL-28(补充) Approval Labeling STANDARD
1999/02/19 SUPPL-24(补充) Approval Labeling STANDARD
1998/12/17 SUPPL-33(补充) Approval Manufacturing (CMC) STANDARD
1998/10/23 SUPPL-32(补充) Approval Manufacturing (CMC) STANDARD
1998/08/25 SUPPL-36(补充) Approval Labeling STANDARD
1998/05/11 SUPPL-31(补充) Approval Manufacturing (CMC) STANDARD
1997/03/18 SUPPL-30(补充) Approval Efficacy STANDARD
1996/12/31 SUPPL-29(补充) Approval Efficacy STANDARD
1996/12/31 SUPPL-18(补充) Approval Labeling STANDARD
1995/07/06 SUPPL-26(补充) Approval Manufacturing (CMC) STANDARD
1994/04/26 SUPPL-27(补充) Approval Efficacy STANDARD
1993/07/22 SUPPL-25(补充) Approval Manufacturing (CMC) STANDARD
1993/03/12 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
1993/02/26 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
1993/02/26 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
1991/09/19 SUPPL-20(补充) Approval Labeling STANDARD
1991/09/19 SUPPL-15(补充) Approval Labeling STANDARD
1990/10/04 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
1990/10/04 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
1989/09/29 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1988/10/17 SUPPL-5(补充) Approval Labeling STANDARD
1988/02/25 SUPPL-12(补充) Approval Labeling STANDARD
1987/08/20 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1987/05/26 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1987/05/26 SUPPL-9(补充) Approval Labeling STANDARD
1987/02/25 SUPPL-8(补充) Approval Labeling STANDARD
1986/05/28 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1986/05/28 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1985/12/20 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity STANDARD
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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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
与本品治疗等效的药品
本品无治疗等效药品
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