药品注册申请号:018024
申请类型:NDA (新药申请)
申请人:ENDO OPERATIONS
申请人全名:ENDO OPERATIONS LTD
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 NUBAIN NALBUPHINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1979/05/15 Approved Prior to Jan 1, 1982 Discontinued
002 NUBAIN NALBUPHINE HYDROCHLORIDE INJECTABLE;INJECTION 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1982/05/27 Discontinued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
2023/12/15 SUPPL-43(补充) Approval Labeling STANDARD
2019/10/07 SUPPL-42(补充) Approval Labeling STANDARD
2016/12/16 SUPPL-41(补充) Approval Labeling STANDARD
2005/08/23 SUPPL-40(补充) Approval Labeling STANDARD
2003/04/30 SUPPL-36(补充) Approval Labeling STANDARD
2002/10/25 SUPPL-39(补充) Approval Manufacturing (CMC) STANDARD
2002/04/16 SUPPL-37(补充) Approval Manufacturing (CMC) STANDARD
2002/01/15 SUPPL-38(补充) Approval Manufacturing (CMC) STANDARD
1995/12/15 SUPPL-35(补充) Approval Manufacturing (CMC) STANDARD
1994/11/02 SUPPL-32(补充) Approval Labeling
1993/10/15 SUPPL-33(补充) Approval Manufacturing (CMC) STANDARD
1990/10/19 SUPPL-31(补充) Approval Manufacturing (CMC) STANDARD
1988/11/10 SUPPL-29(补充) Approval Manufacturing (CMC) STANDARD
1988/11/10 SUPPL-27(补充) Approval Labeling
1988/03/03 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
1987/12/07 SUPPL-28(补充) Approval Manufacturing (CMC) STANDARD
1987/08/04 SUPPL-26(补充) Approval Labeling
1986/10/23 SUPPL-16(补充) Approval Efficacy
1984/11/28 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
1984/09/17 SUPPL-20(补充) Approval Manufacturing (CMC) STANDARD
1984/09/13 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
1984/09/13 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
1984/03/02 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1984/03/02 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1983/08/17 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
1983/08/17 SUPPL-18(补充) Approval Manufacturing (CMC) STANDARD
1983/02/16 SUPPL-17(补充) Approval Labeling
1982/05/27 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1982/05/27 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1982/05/20 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1982/05/20 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1981/04/01 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1981/02/20 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1980/02/21 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1980/01/24 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1979/06/28 SUPPL-1(补充) Approval Labeling
1979/05/15 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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