药品注册申请号:012911
申请类型:NDA (新药申请)
申请人:HRA PHARMA
申请人全名:HRA PHARMA RARE DISEASES
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 METOPIRONE METYRAPONE TABLET;ORAL 250MG No No None 1961/12/04 Approved Prior to Jan 1, 1982 Discontinued
002 METOPIRONE METYRAPONE CAPSULE;ORAL 250MG Yes Yes None 1996/08/09 Prescription
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
2023/07/25 SUPPL-39(补充) Approval Labeling STANDARD
2022/09/08 SUPPL-38(补充) Approval Labeling STANDARD
2020/02/20 SUPPL-36(补充) Approval Labeling STANDARD
2018/10/22 SUPPL-35(补充) Approval Labeling STANDARD
2014/08/14 SUPPL-34(补充) Approval Manufacturing (CMC) PRIORITY
2013/09/20 SUPPL-32(补充) Approval Manufacturing (CMC) PRIORITY
2013/09/05 SUPPL-33(补充) Approval Manufacturing (CMC) PRIORITY
2013/06/28 SUPPL-31(补充) Approval Manufacturing (CMC) PRIORITY
2013/01/19 SUPPL-30(补充) Approval Manufacturing (CMC) PRIORITY
2010/11/04 SUPPL-26(补充) Approval Labeling STANDARD
2004/05/07 SUPPL-23(补充) Approval Labeling STANDARD
1999/04/21 SUPPL-20(补充) Approval Manufacturing (CMC) PRIORITY
1999/02/09 SUPPL-19(补充) Approval Manufacturing (CMC) PRIORITY
1996/06/27 SUPPL-18(补充) Approval Manufacturing (CMC) PRIORITY
1995/08/09 SUPPL-17(补充) Approval Manufacturing (CMC) PRIORITY
1992/06/12 SUPPL-16(补充) Approval Manufacturing (CMC) PRIORITY
1992/03/26 SUPPL-14(补充) Approval Manufacturing (CMC) PRIORITY
1992/03/13 SUPPL-15(补充) Approval Labeling
1986/02/10 SUPPL-13(补充) Approval Labeling
1986/01/10 SUPPL-12(补充) Approval Labeling
1984/08/29 SUPPL-11(补充) Approval Manufacturing (CMC) PRIORITY
1983/01/17 SUPPL-10(补充) Approval Labeling
1978/02/03 SUPPL-9(补充) Approval Manufacturing (CMC) PRIORITY
1976/03/02 SUPPL-8(补充) Approval Labeling
1961/12/04 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity PRIORITY
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
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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药品NDC数据与药品包装、标签说明书
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