药品注册申请号:020405
申请类型:NDA (新药申请)
申请人:CONCORDIA
申请人全名:CONCORDIA 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 LANOXIN DIGOXIN TABLET;ORAL 0.0625MG Yes No AB 1997/09/30 1997/09/30 Prescription
002 LANOXIN DIGOXIN TABLET;ORAL 0.125MG Yes No AB 1997/09/30 Prescription
003 LANOXIN DIGOXIN TABLET;ORAL 0.1875MG Yes No None 1997/09/30 Discontinued
004 LANOXIN DIGOXIN TABLET;ORAL 0.25MG Yes Yes AB 1997/09/30 Prescription
005 LANOXIN DIGOXIN TABLET;ORAL 0.375MG No No None 1997/09/30 Discontinued
006 LANOXIN DIGOXIN TABLET;ORAL 0.5MG No No None 1997/09/30 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
2024/04/29 SUPPL-17(补充) Approval Labeling STANDARD
2019/02/22 SUPPL-15(补充) Approval Labeling STANDARD
2018/08/24 SUPPL-14(补充) Approval Labeling STANDARD
2016/12/01 SUPPL-13(补充) Approval Labeling STANDARD
2015/09/03 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
2015/07/28 SUPPL-11(补充) Approval Labeling STANDARD
2013/11/22 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
2013/10/17 SUPPL-7(补充) Approval Labeling STANDARD
2013/05/21 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
2012/08/13 SUPPL-5(补充) Approval Labeling UNKNOWN
2011/11/14 SUPPL-6(补充) Approval Labeling UNKNOWN
2010/02/05 SUPPL-4(补充) Approval Labeling UNKNOWN
2000/12/07 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1999/02/19 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1997/09/30 ORIG-1(原始申请) Approval Type 7 - Drug Already Marketed without Approved NDA 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
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:DIGOXIN 剂型/给药途径:TABLET;ORAL 规格:0.0625MG 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
020405 001 NDA LANOXIN DIGOXIN TABLET;ORAL 0.0625MG Prescription Yes No AB 1997/09/30 CONCORDIA
214982 001 ANDA DIGOXIN DIGOXIN TABLET;ORAL 0.0625MG Prescription No No AB 2022/02/08 AUROBINDO PHARMA LTD
215307 003 ANDA DIGOXIN DIGOXIN TABLET;ORAL 0.0625MG Prescription No No AB 2022/08/25 NOVITIUM PHARMA
活性成分:DIGOXIN 剂型/给药途径:TABLET;ORAL 规格:0.125MG 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
020405 002 NDA LANOXIN DIGOXIN TABLET;ORAL 0.125MG Prescription Yes No AB 1997/09/30 CONCORDIA
040282 001 ANDA DIGOXIN DIGOXIN TABLET;ORAL 0.125MG Prescription No No AB 1999/12/23 RISING
076268 001 ANDA DIGOXIN DIGOXIN TABLET;ORAL 0.125MG Prescription No No AB 2002/07/26 STEVENS J
076363 001 ANDA DIGOXIN DIGOXIN TABLET;ORAL 0.125MG Prescription No No AB 2003/01/31 SUN PHARM INDS INC
077002 002 ANDA DIGOXIN DIGOXIN TABLET;ORAL 0.125MG Prescription No No AB 2007/10/30 HIKMA INTL PHARMS
078556 001 ANDA DIGOXIN DIGOXIN TABLET;ORAL 0.125MG Prescription No No AB 2009/07/20 IMPAX LABS
215307 001 ANDA DIGOXIN DIGOXIN TABLET;ORAL 0.125MG Prescription No No AB 2021/11/22 NOVITIUM PHARMA
214982 002 ANDA DIGOXIN DIGOXIN TABLET;ORAL 0.125MG Prescription No No AB 2022/02/08 AUROBINDO PHARMA LTD
活性成分:DIGOXIN 剂型/给药途径:TABLET;ORAL 规格:0.25MG 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
020405 004 NDA LANOXIN DIGOXIN TABLET;ORAL 0.25MG Prescription Yes Yes AB 1997/09/30 CONCORDIA
040282 002 ANDA DIGOXIN DIGOXIN TABLET;ORAL 0.25MG Prescription No No AB 1999/12/23 RISING
076268 002 ANDA DIGOXIN DIGOXIN TABLET;ORAL 0.25MG Prescription No No AB 2002/07/26 STEVENS J
076363 002 ANDA DIGOXIN DIGOXIN TABLET;ORAL 0.25MG Prescription No No AB 2003/01/31 SUN PHARM INDS INC
077002 001 ANDA DIGOXIN DIGOXIN TABLET;ORAL 0.25MG Prescription No No AB 2007/10/30 HIKMA INTL PHARMS
078556 002 ANDA DIGOXIN DIGOXIN TABLET;ORAL 0.25MG Prescription No No AB 2009/07/20 IMPAX LABS
215307 002 ANDA DIGOXIN DIGOXIN TABLET;ORAL 0.25MG Prescription No No AB 2021/11/22 NOVITIUM PHARMA
214982 003 ANDA DIGOXIN DIGOXIN TABLET;ORAL 0.25MG Prescription No No AB 2022/02/08 AUROBINDO PHARMA LTD
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