美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=REQUIP"
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
REQUIP 020658 001 NDA 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HYDROCHLORIDE TABLET;ORAL EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1997/09/19 1997/09/19 GLAXOSMITHKLINE LLC Discontinued
REQUIP 020658 002 NDA 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HYDROCHLORIDE TABLET;ORAL EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1997/09/19 1997/09/19 GLAXOSMITHKLINE LLC Discontinued
REQUIP 020658 003 NDA ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1997/09/19 1997/09/19 GLAXOSMITHKLINE LLC Discontinued
REQUIP 020658 004 NDA ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1997/09/19 1997/09/19 GLAXOSMITHKLINE LLC Discontinued
REQUIP 020658 005 NDA ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1997/09/19 1997/09/19 GLAXOSMITHKLINE LLC Discontinued
REQUIP 020658 006 NDA ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1997/09/19 1999/01/27 GLAXOSMITHKLINE LLC Discontinued
REQUIP 020658 007 NDA ROPINIROLE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1997/09/19 1999/01/27 GLAXOSMITHKLINE LLC Discontinued
REQUIP XL 022008 001 NDA ROPINIROLE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2008/06/13 2008/06/13 GLAXOSMITHKLINE LLC Discontinued
REQUIP XL 022008 002 NDA ROPINIROLE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2008/06/13 2008/06/13 GLAXOSMITHKLINE LLC Discontinued
REQUIP XL 022008 003 NDA ROPINIROLE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2008/06/13 2008/06/13 GLAXOSMITHKLINE LLC Discontinued
REQUIP XL 022008 004 NDA ROPINIROLE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2008/06/13 2008/06/13 GLAXOSMITHKLINE LLC Discontinued
REQUIP XL 022008 005 NDA ROPINIROLE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2008/06/13 2008/10/31 GLAXOSMITHKLINE LLC Discontinued
REQUIP XL 022008 006 NDA ROPINIROLE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2008/06/13 2009/04/10 GLAXOSMITHKLINE LLC Discontinued
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