药品注册申请号:020658
申请类型:NDA (新药申请)
申请人:GLAXOSMITHKLINE LLC
申请人全名:GLAXOSMITHKLINE 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 REQUIP ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1997/09/19 1997/09/19 Discontinued
002 REQUIP ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1997/09/19 Discontinued
003 REQUIP ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1997/09/19 Discontinued
004 REQUIP ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1997/09/19 Discontinued
005 REQUIP ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1997/09/19 Discontinued
006 REQUIP ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1999/01/27 Discontinued
007 REQUIP ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1999/01/27 Discontinued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
2021/07/12 SUPPL-38(补充) Approval Labeling STANDARD
2020/04/03 SUPPL-37(补充) Approval Labeling 901 REQUIRED
2017/05/05 SUPPL-34(补充) Approval Labeling STANDARD
2016/09/09 SUPPL-33(补充) Approval Labeling STANDARD
2014/08/28 SUPPL-32(补充) Approval Labeling STANDARD
2014/08/28 SUPPL-30(补充) Approval Labeling UNKNOWN
2014/08/28 SUPPL-27(补充) Approval Labeling STANDARD
2014/08/28 SUPPL-26(补充) Approval Labeling STANDARD
2014/08/28 SUPPL-24(补充) Approval Labeling STANDARD
2012/03/19 SUPPL-31(补充) Approval Labeling STANDARD
2008/12/31 SUPPL-21(补充) Approval Labeling STANDARD
2008/12/31 SUPPL-20(补充) Approval Labeling STANDARD
2008/12/31 SUPPL-18(补充) Approval Labeling STANDARD
2005/05/04 SUPPL-13(补充) Approval Efficacy PRIORITY
2003/06/19 SUPPL-12(补充) Approval Labeling STANDARD
2002/10/22 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
2001/07/05 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
2001/04/03 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
2001/03/01 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
2000/05/15 SUPPL-7(补充) Approval Labeling STANDARD
2000/05/15 SUPPL-3(补充) Approval Labeling STANDARD
1999/11/02 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1999/08/16 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1999/01/27 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1997/09/19 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
001 4452808 2007/12/07 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
4824860 2008/05/19 U-212 PDF格式**本条是由Drugfuture回溯的历史信息**
002 4452808 2007/12/07 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
4824860 2008/05/19 U-212 PDF格式**本条是由Drugfuture回溯的历史信息**
003 4452808 2007/12/07 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
4824860 2008/05/19 U-212 PDF格式**本条是由Drugfuture回溯的历史信息**
004 4452808 2007/12/07 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
4824860 2008/05/19 U-212 PDF格式**本条是由Drugfuture回溯的历史信息**
005 4452808 2007/12/07 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
4824860 2008/05/19 U-212 PDF格式**本条是由Drugfuture回溯的历史信息**
006 4452808 2007/12/07 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
4824860 2008/05/19 U-212 PDF格式**本条是由Drugfuture回溯的历史信息**
007 4452808 2007/12/07 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
4824860 2008/05/19 U-212 PDF格式**本条是由Drugfuture回溯的历史信息**
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
001 I-464 2008/05/04**本条是由Drugfuture回溯的历史信息**
002 I-464 2008/05/04**本条是由Drugfuture回溯的历史信息**
003 I-464 2008/05/04**本条是由Drugfuture回溯的历史信息**
004 I-464 2008/05/04**本条是由Drugfuture回溯的历史信息**
005 I-464 2008/05/04**本条是由Drugfuture回溯的历史信息**
006 I-464 2008/05/04**本条是由Drugfuture回溯的历史信息**
007 I-464 2008/05/04**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
本品无治疗等效药品
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