药品注册申请号:019865
申请类型:NDA (新药申请)
申请人:COVIS PHARMA BV
申请人全名:COVIS PHARMA BV
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 BETAPACE SOTALOL HYDROCHLORIDE TABLET;ORAL 80MG Yes No AB 1992/10/30 1992/10/30 Prescription
002 BETAPACE SOTALOL HYDROCHLORIDE TABLET;ORAL 160MG Yes Yes AB 1992/10/30 Prescription
003 BETAPACE SOTALOL HYDROCHLORIDE TABLET;ORAL 240MG Yes No AB 1992/10/30 Prescription
004 BETAPACE SOTALOL HYDROCHLORIDE TABLET;ORAL 320MG No No None 1992/10/30 Discontinued
005 BETAPACE SOTALOL HYDROCHLORIDE TABLET;ORAL 120MG Yes No AB 1994/04/20 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2016/05/10 SUPPL 21 Approval Labeling STANDARD
2011/08/17 SUPPL 20 Approval Labeling UNKNOWN
2011/02/03 SUPPL 19 Approval Labeling UNKNOWN
2001/10/01 SUPPL 10 Approval Efficacy STANDARD
2001/07/26 SUPPL 14 Approval Manufacturing (CMC) PRIORITY
2000/11/22 SUPPL 12 Approval Manufacturing (CMC) PRIORITY
2000/07/07 SUPPL 11 Approval Labeling STANDARD
1999/08/23 SUPPL 8 Approval Labeling STANDARD
1999/04/09 SUPPL 9 Approval Manufacturing (CMC) PRIORITY
1995/12/04 SUPPL 6 Approval Manufacturing (CMC) PRIORITY
1995/07/26 SUPPL 5 Approval Labeling STANDARD
1994/09/06 SUPPL 3 Approval Manufacturing (CMC) PRIORITY
1994/04/20 SUPPL 4 Approval Labeling STANDARD
1994/04/20 SUPPL 2 Approval Manufacturing (CMC) PRIORITY
1993/04/13 SUPPL 1 Approval Manufacturing (CMC) PRIORITY
1992/10/30 ORIG 1 Approval Type 1 - New Molecular Entity PRIORITY
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:SOTALOL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:80MG 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
019865 001 NDA BETAPACE SOTALOL HYDROCHLORIDE TABLET;ORAL 80MG Prescription Yes No AB 1992/10/30 COVIS PHARMA BV
021151 001 NDA BETAPACE AF SOTALOL HYDROCHLORIDE TABLET;ORAL 80MG Prescription Yes No AB 2000/02/22 COVIS PHARMA BV
075429 001 ANDA SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 2000/05/01 TEVA
075500 001 ANDA SORINE SOTALOL HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 2001/04/27 UPSHER SMITH LABS
076140 001 ANDA SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 2002/09/26 APOTEX
076214 001 ANDA SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 2003/08/27 APOTEX
075563 001 ANDA SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 2003/11/07 OXFORD PHARMS
077070 001 ANDA SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 2005/11/04 EPIC PHARMA INC
077616 001 ANDA SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 2007/02/07 MYLAN
207428 001 ANDA SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 2016/10/21 BEXIMCO PHARMS USA
207429 001 ANDA SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 2018/11/02 BEXIMCO PHARMS USA
活性成分:SOTALOL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:160MG 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
019865 002 NDA BETAPACE SOTALOL HYDROCHLORIDE TABLET;ORAL 160MG Prescription Yes Yes AB 1992/10/30 COVIS PHARMA BV
021151 003 NDA BETAPACE AF SOTALOL HYDROCHLORIDE TABLET;ORAL 160MG Prescription Yes Yes AB 2000/02/22 COVIS PHARMA BV
075429 003 ANDA SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 160MG Prescription No No AB 2000/05/01 TEVA
075500 002 ANDA SORINE SOTALOL HYDROCHLORIDE TABLET;ORAL 160MG Prescription No No AB 2001/04/27 UPSHER SMITH LABS
076140 003 ANDA SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 160MG Prescription No No AB 2002/09/26 APOTEX
076214 003 ANDA SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 160MG Prescription No No AB 2003/08/27 APOTEX
075563 003 ANDA SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 160MG Prescription No No AB 2003/11/07 OXFORD PHARMS
077070 003 ANDA SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 160MG Prescription No No AB 2005/11/04 EPIC PHARMA INC
077616 003 ANDA SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 160MG Prescription No No AB 2007/02/07 MYLAN
207428 003 ANDA SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 160MG Prescription No No AB 2016/10/21 BEXIMCO PHARMS USA
207429 003 ANDA SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 160MG Prescription No No AB 2018/11/02 BEXIMCO PHARMS USA
活性成分:SOTALOL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:240MG 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
019865 003 NDA BETAPACE SOTALOL HYDROCHLORIDE TABLET;ORAL 240MG Prescription Yes No AB 1992/10/30 COVIS PHARMA BV
075429 004 ANDA SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 240MG Prescription No No AB 2000/05/01 TEVA
075500 003 ANDA SORINE SOTALOL HYDROCHLORIDE TABLET;ORAL 240MG Prescription No No AB 2001/04/27 UPSHER SMITH LABS
076140 004 ANDA SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 240MG Prescription No No AB 2002/09/26 APOTEX
075563 004 ANDA SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 240MG Prescription No No AB 2003/11/07 OXFORD PHARMS
活性成分:SOTALOL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:120MG 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
019865 005 NDA BETAPACE SOTALOL HYDROCHLORIDE TABLET;ORAL 120MG Prescription Yes No AB 1994/04/20 COVIS PHARMA BV
021151 002 NDA BETAPACE AF SOTALOL HYDROCHLORIDE TABLET;ORAL 120MG Prescription Yes No AB 2000/02/22 COVIS PHARMA BV
075429 002 ANDA SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 2000/05/01 TEVA
075500 004 ANDA SORINE SOTALOL HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 2001/04/27 UPSHER SMITH LABS
076140 002 ANDA SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 2002/09/26 APOTEX
076214 002 ANDA SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 2003/08/27 APOTEX
075563 002 ANDA SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 2003/11/07 OXFORD PHARMS
077070 002 ANDA SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 2005/11/04 EPIC PHARMA INC
077616 002 ANDA SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 2007/02/07 MYLAN
207428 002 ANDA SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 2016/10/21 BEXIMCO PHARMS USA
207429 002 ANDA SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 2018/11/02 BEXIMCO PHARMS USA
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