美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=BETAPACE"
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
BETAPACE 019865 001 NDA SOTALOL HYDROCHLORIDE TABLET;ORAL 80MG Yes No 1992/10/30 1992/10/30 COVIS PHARMA BV Prescription
BETAPACE 019865 002 NDA SOTALOL HYDROCHLORIDE TABLET;ORAL 160MG Yes Yes 1992/10/30 1992/10/30 COVIS PHARMA BV Prescription
BETAPACE 019865 003 NDA SOTALOL HYDROCHLORIDE TABLET;ORAL 240MG Yes No 1992/10/30 1992/10/30 COVIS PHARMA BV Prescription
BETAPACE 019865 004 NDA SOTALOL HYDROCHLORIDE TABLET;ORAL 320MG No No 1992/10/30 1992/10/30 COVIS PHARMA BV Discontinued
BETAPACE 019865 005 NDA SOTALOL HYDROCHLORIDE TABLET;ORAL 120MG Yes No 1992/10/30 1994/04/20 COVIS PHARMA BV Prescription
BETAPACE AF 021151 001 NDA SOTALOL HYDROCHLORIDE TABLET;ORAL 80MG Yes No 2000/02/22 2000/02/22 COVIS PHARMA BV Prescription
BETAPACE AF 021151 002 NDA SOTALOL HYDROCHLORIDE TABLET;ORAL 120MG Yes No 2000/02/22 2000/02/22 COVIS PHARMA BV Prescription
BETAPACE AF 021151 003 NDA SOTALOL HYDROCHLORIDE TABLET;ORAL 160MG Yes Yes 2000/02/22 2000/02/22 COVIS PHARMA BV Prescription
BETAPACE AF 021151 005 NDA SOTALOL HYDROCHLORIDE TABLET;ORAL 100MG No No 2000/02/22 2003/03/14 COVIS PHARMA BV Discontinued
BETAPACE AF 021151 006 NDA SOTALOL HYDROCHLORIDE TABLET;ORAL 40MG No No 2000/02/22 2003/04/02 COVIS PHARMA BV Discontinued
BETAPACE AF 021151 007 NDA SOTALOL HYDROCHLORIDE TABLET;ORAL 60MG No No 2000/02/22 2003/04/02 COVIS PHARMA BV Discontinued
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