药品注册申请号:086881
申请类型:ANDA (仿制药申请)
申请人:CHARTWELL RX
申请人全名:CHARTWELL RX SCIENCES 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 SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; SPIRONOLACTONE TABLET;ORAL 25MG;25MG No No None 1980/07/10 Approved Prior to Jan 1, 1982 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
2001/05/09 SUPPL-44(补充) Approval Manufacturing (CMC)
1998/12/01 SUPPL-42(补充) Approval Manufacturing (CMC)
1998/12/01 SUPPL-41(补充) Approval Manufacturing (CMC)
1998/06/10 SUPPL-43(补充) Approval Labeling
1997/10/21 SUPPL-40(补充) Approval Manufacturing (CMC)
1996/02/07 SUPPL-39(补充) Approval Manufacturing (CMC)
1994/06/20 SUPPL-38(补充) Approval Manufacturing (CMC)
1990/12/27 SUPPL-36(补充) Approval Labeling
1990/05/23 SUPPL-37(补充) Approval Labeling
1989/03/31 SUPPL-35(补充) Approval Manufacturing (CMC)
1989/03/31 SUPPL-34(补充) Approval Manufacturing (CMC)
1986/09/29 SUPPL-33(补充) Approval Manufacturing (CMC)
1986/09/29 SUPPL-31(补充) Approval Manufacturing (CMC)
1986/09/29 SUPPL-30(补充) Approval Manufacturing (CMC)
1986/07/17 SUPPL-29(补充) Approval Manufacturing (CMC)
1985/10/08 SUPPL-24(补充) Approval Manufacturing (CMC)
1984/06/29 SUPPL-27(补充) Approval Manufacturing (CMC)
1984/04/11 SUPPL-26(补充) Approval Manufacturing (CMC)
1984/04/11 SUPPL-25(补充) Approval Manufacturing (CMC)
1983/08/11 SUPPL-23(补充) Approval Manufacturing (CMC)
1983/08/11 SUPPL-22(补充) Approval Manufacturing (CMC)
1983/01/27 SUPPL-21(补充) Approval Manufacturing (CMC)
1983/01/27 SUPPL-19(补充) Approval Manufacturing (CMC)
1983/01/27 SUPPL-18(补充) Approval Manufacturing (CMC)
1982/05/24 SUPPL-17(补充) Approval Manufacturing (CMC)
1982/05/24 SUPPL-16(补充) Approval Manufacturing (CMC)
1982/05/19 SUPPL-6(补充) Approval Manufacturing (CMC)
1982/05/19 SUPPL-4(补充) Approval Manufacturing (CMC)
1980/07/10 ORIG-1(原始申请) Approval
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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