药品注册申请号：077316
申请类型：ANDA (仿制药申请)
申请人：MYLAN
申请人全名：MYLAN PHARMACEUTICALS 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 CARVEDILOL CARVEDILOL TABLET;ORAL 3.125MG No No AB 2007/09/05 2007/09/05 Discontinued
002 CARVEDILOL CARVEDILOL TABLET;ORAL 6.25MG No No AB 2007/09/05 Prescription
003 CARVEDILOL CARVEDILOL TABLET;ORAL 12.5MG No No AB 2007/09/05 Prescription
004 CARVEDILOL CARVEDILOL TABLET;ORAL 25MG No No AB 2007/09/05 Prescription
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
2020/03/03 SUPPL-16（补充） Approval Labeling STANDARD
2016/04/04 SUPPL-14（补充） Approval Labeling STANDARD
2014/09/19 SUPPL-11（补充） Approval Labeling STANDARD
2013/06/13 SUPPL-6（补充） Approval Labeling
2011/04/21 SUPPL-5（补充） Approval Labeling
2011/02/14 SUPPL-3（补充） Approval Labeling
2007/09/05 ORIG-1（原始申请） Approval
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
无
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
无
与本品治疗等效的药品
活性成分:CARVEDILOL 剂型/给药途径:TABLET;ORAL 规格:3.125MG 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
020297 004 NDA COREG CARVEDILOL TABLET;ORAL 3.125MG Prescription Yes No AB 1997/05/29 WAYLIS THERAP
076373 001 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 3.125MG Prescription No No AB 2007/09/05 TEVA
076649 001 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 3.125MG Prescription No No AB 2007/09/05 DR REDDYS LABS LTD
076989 001 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 3.125MG Discontinued No No AB 2007/09/05 SUN PHARM INDS LTD
077316 001 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 3.125MG Discontinued No No AB 2007/09/05 MYLAN
077474 001 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 3.125MG Prescription No No AB 2007/09/05 CHARTWELL MOLECULAR
077614 004 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 3.125MG Prescription No No AB 2007/09/05 ZYDUS PHARMS USA INC
077780 001 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 3.125MG Prescription No No AB 2007/09/05 TARO
078165 001 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 3.125MG Prescription No No AB 2007/09/05 RUBICON
078217 001 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 3.125MG Prescription No No AB 2007/09/05 LUPIN
078227 001 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 3.125MG Prescription No No AB 2007/09/05 SANDOZ
078251 001 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 3.125MG Prescription No No AB 2007/09/05 GLENMARK PHARMS LTD
078332 001 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 3.125MG Prescription No No AB 2007/09/05 AUROBINDO PHARMA
078384 001 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 3.125MG Prescription No No AB 2007/09/05 BEXIMCO USA
078786 001 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 3.125MG Prescription No No AB 2009/12/22 MLV
活性成分:CARVEDILOL 剂型/给药途径:TABLET;ORAL 规格:6.25MG 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
020297 003 NDA COREG CARVEDILOL TABLET;ORAL 6.25MG Prescription Yes No AB 1995/09/14 WAYLIS THERAP
076373 002 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 6.25MG Prescription No No AB 2007/09/05 TEVA
076649 002 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 6.25MG Prescription No No AB 2007/09/05 DR REDDYS LABS LTD
076989 002 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 6.25MG Discontinued No No AB 2007/09/05 SUN PHARM INDS LTD
077316 002 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 6.25MG Prescription No No AB 2007/09/05 MYLAN
077474 002 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 6.25MG Prescription No No AB 2007/09/05 CHARTWELL MOLECULAR
077614 001 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 6.25MG Prescription No No AB 2007/09/05 ZYDUS PHARMS USA INC
077780 002 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 6.25MG Prescription No No AB 2007/09/05 TARO
078165 002 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 6.25MG Prescription No No AB 2007/09/05 RUBICON
078217 002 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 6.25MG Prescription No No AB 2007/09/05 LUPIN
078227 002 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 6.25MG Prescription No No AB 2007/09/05 SANDOZ
078251 002 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 6.25MG Prescription No No AB 2007/09/05 GLENMARK PHARMS LTD
078332 002 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 6.25MG Prescription No No AB 2007/09/05 AUROBINDO PHARMA
078384 002 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 6.25MG Prescription No No AB 2007/09/05 BEXIMCO USA
078786 002 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 6.25MG Prescription No No AB 2009/12/22 MLV
活性成分:CARVEDILOL 剂型/给药途径:TABLET;ORAL 规格:12.5MG 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
020297 002 NDA COREG CARVEDILOL TABLET;ORAL 12.5MG Prescription Yes Yes AB 1995/09/14 WAYLIS THERAP
076373 003 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 12.5MG Prescription No No AB 2007/09/05 TEVA
076649 003 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 12.5MG Prescription No No AB 2007/09/05 DR REDDYS LABS LTD
076989 003 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 12.5MG Discontinued No No AB 2007/09/05 SUN PHARM INDS LTD
077316 003 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 12.5MG Prescription No No AB 2007/09/05 MYLAN
077474 003 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 12.5MG Prescription No No AB 2007/09/05 CHARTWELL MOLECULAR
077614 002 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 12.5MG Prescription No No AB 2007/09/05 ZYDUS PHARMS USA INC
077780 003 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 12.5MG Prescription No No AB 2007/09/05 TARO
078165 003 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 12.5MG Prescription No No AB 2007/09/05 RUBICON
078217 003 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 12.5MG Prescription No No AB 2007/09/05 LUPIN
078227 003 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 12.5MG Prescription No No AB 2007/09/05 SANDOZ
078251 003 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 12.5MG Prescription No No AB 2007/09/05 GLENMARK PHARMS LTD
078332 003 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 12.5MG Prescription No No AB 2007/09/05 AUROBINDO PHARMA
078384 003 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 12.5MG Prescription No No AB 2007/09/05 BEXIMCO USA
078786 003 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 12.5MG Prescription No No AB 2009/12/22 MLV
活性成分:CARVEDILOL 剂型/给药途径:TABLET;ORAL 规格:25MG 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
020297 001 NDA COREG CARVEDILOL TABLET;ORAL 25MG Prescription Yes No AB 1995/09/14 WAYLIS THERAP
076373 004 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 25MG Prescription No No AB 2007/09/05 TEVA
076649 004 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 25MG Prescription No No AB 2007/09/05 DR REDDYS LABS LTD
076989 004 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 25MG Discontinued No No AB 2007/09/05 SUN PHARM INDS LTD
077316 004 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 25MG Prescription No No AB 2007/09/05 MYLAN
077474 004 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 25MG Prescription No No AB 2007/09/05 CHARTWELL MOLECULAR
077614 003 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 25MG Prescription No No AB 2007/09/05 ZYDUS PHARMS USA INC
077780 004 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 25MG Prescription No No AB 2007/09/05 TARO
078165 004 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 25MG Prescription No No AB 2007/09/05 RUBICON
078217 004 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 25MG Prescription No No AB 2007/09/05 LUPIN
078227 004 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 25MG Prescription No No AB 2007/09/05 SANDOZ
078251 004 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 25MG Prescription No No AB 2007/09/05 GLENMARK PHARMS LTD
078332 004 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 25MG Prescription No No AB 2007/09/05 AUROBINDO PHARMA
078384 004 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 25MG Prescription No No AB 2007/09/05 BEXIMCO USA
078786 004 ANDA CARVEDILOL CARVEDILOL TABLET;ORAL 25MG Prescription No No AB 2009/12/22 MLV
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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