药品注册申请号:018200
申请类型:NDA (新药申请)
申请人:PADAGIS US
申请人全名:PADAGIS US LLC
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 MIDAMOR AMILORIDE HYDROCHLORIDE TABLET;ORAL 5MG Yes No AB 1981/10/05 Approved Prior to Jan 1, 1982 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
2003/02/25 SUPPL-26(补充) Approval Labeling STANDARD
2002/06/24 SUPPL-25(补充) Approval Manufacturing (CMC) STANDARD
2002/03/21 SUPPL-24(补充) Approval Labeling STANDARD
2001/09/18 SUPPL-23(补充) Approval Labeling STANDARD
2000/11/21 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
1998/02/12 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
1992/09/16 SUPPL-20(补充) Approval Labeling
1992/03/26 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
1991/05/14 SUPPL-18(补充) Approval Manufacturing (CMC) STANDARD
1989/04/12 SUPPL-17(补充) Approval Labeling
1988/06/22 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1988/05/05 SUPPL-10(补充) Approval Labeling
1988/03/29 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
1987/06/01 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1987/03/09 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1986/01/21 SUPPL-12(补充) Approval Labeling
1985/11/01 SUPPL-11(补充) Approval Labeling
1985/09/10 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1985/06/14 SUPPL-8(补充) Approval Labeling
1985/02/07 SUPPL-7(补充) Approval Labeling
1984/01/04 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1983/12/23 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1983/03/01 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1982/07/08 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1982/03/03 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1982/02/08 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1981/10/05 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)
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
活性成分:AMILORIDE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:5MG 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
018200 001 NDA MIDAMOR AMILORIDE HYDROCHLORIDE TABLET;ORAL 5MG Prescription Yes No AB Approved Prior to Jan 1, 1982 PADAGIS US
070346 001 ANDA AMILORIDE HYDROCHLORIDE AMILORIDE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No Yes AB 1986/01/22 ENDO OPERATIONS
079133 001 ANDA AMILORIDE HYDROCHLORIDE AMILORIDE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2009/01/30 SIGMAPHARM LABS LLC
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