药品注册申请号:018716
申请类型:NDA (新药申请)
申请人:ALVOGEN
申请人全名:ALVOGEN INC
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 TRANDATE LABETALOL HYDROCHLORIDE TABLET;ORAL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1984/08/01 1985/05/24 Discontinued
002 TRANDATE LABETALOL HYDROCHLORIDE TABLET;ORAL 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 1984/08/01 Discontinued
003 TRANDATE LABETALOL HYDROCHLORIDE TABLET;ORAL 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AB 1984/08/01 Discontinued
004 TRANDATE LABETALOL HYDROCHLORIDE TABLET;ORAL 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1984/08/01 Discontinued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
2024/04/25 SUPPL-36(补充) Approval Labeling STANDARD
2016/04/27 SUPPL-28(补充) Approval Labeling STANDARD
2014/10/27 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
2010/11/22 SUPPL-26(补充) Approval Labeling UNKNOWN
2008/02/01 SUPPL-25(补充) Approval Labeling STANDARD
2003/04/23 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
1998/08/13 SUPPL-22(补充) Approval Labeling STANDARD
1997/04/21 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
1993/05/27 SUPPL-20(补充) Approval Labeling STANDARD
1993/05/27 SUPPL-18(补充) Approval Labeling
1991/06/05 SUPPL-19(补充) Approval Labeling
1991/02/01 SUPPL-17(补充) Approval Labeling
1990/11/07 SUPPL-15(补充) Approval Labeling
1990/06/07 SUPPL-16(补充) Approval Labeling
1989/12/22 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1989/06/16 SUPPL-12(补充) Approval Labeling
1989/06/16 SUPPL-11(补充) Approval Labeling
1989/04/07 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1987/09/22 SUPPL-9(补充) Approval Labeling
1987/08/27 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1986/11/13 SUPPL-8(补充) Approval Labeling
1985/08/08 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1985/05/24 SUPPL-6(补充) Approval Labeling
1985/05/24 SUPPL-5(补充) Approval Labeling
1985/04/16 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1985/03/26 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1984/08/01 ORIG-1(原始申请) Approval Type 5 - New Formulation or New Manufacturer 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:LABETALOL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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
018716 002 NDA TRANDATE LABETALOL HYDROCHLORIDE TABLET;ORAL 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 1984/08/01 ALVOGEN
活性成分:LABETALOL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** 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
018716 003 NDA TRANDATE LABETALOL HYDROCHLORIDE TABLET;ORAL 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AB 1984/08/01 ALVOGEN
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