药品注册申请号:075135
申请类型:ANDA (仿制药申请)
申请人:UPSHER SMITH LABS
申请人全名:UPSHER SMITH LABORATORIES LLC
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 PACERONE AMIODARONE HYDROCHLORIDE TABLET;ORAL 200MG No No AB 1998/04/30 1998/04/30 Prescription
002 PACERONE AMIODARONE HYDROCHLORIDE TABLET;ORAL 100MG No No AB 2005/04/12 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
2019/11/01 SUPPL 54 Approval Labeling STANDARD
2019/11/01 SUPPL 52 Approval Labeling STANDARD
2019/11/01 SUPPL 51 Approval Labeling STANDARD
2019/11/01 SUPPL 49 Approval Labeling STANDARD
2019/11/01 SUPPL 35 Approval Labeling
2019/11/01 SUPPL 27 Approval Labeling
2019/11/01 SUPPL 26 Approval Labeling
2015/08/13 SUPPL 48 Approval Labeling STANDARD
2015/08/13 SUPPL 47 Approval Labeling STANDARD
2015/08/13 SUPPL 46 Approval Labeling STANDARD
2015/08/13 SUPPL 45 Approval Labeling STANDARD
2013/06/17 SUPPL 44 Approval Labeling
2013/06/17 SUPPL 43 Approval Labeling
2010/11/30 SUPPL 41 Approval Labeling
2009/12/01 SUPPL 40 Approval Labeling
2009/04/28 SUPPL 39 Approval Labeling
2007/11/16 SUPPL 34 Approval Labeling
2006/04/04 SUPPL 25 Approval Labeling
2006/02/13 SUPPL 18 Approval Labeling
2005/04/12 SUPPL 11 Approval Labeling
2004/10/04 SUPPL 17 Approval Labeling
2004/01/05 SUPPL 16 Approval Labeling
2003/09/24 SUPPL 13 Approval Labeling
2002/12/19 SUPPL 9 Approval Manufacturing (CMC)
2002/08/20 SUPPL 8 Approval Labeling
2000/04/12 SUPPL 7 Approval Labeling
2000/04/12 SUPPL 6 Approval Manufacturing (CMC)
2000/04/12 SUPPL 5 Approval Manufacturing (CMC)
2000/02/01 SUPPL 4 Approval Bioequivalence
1999/12/02 SUPPL 2 Approval Manufacturing (CMC)
1999/12/02 SUPPL 1 Approval Manufacturing (CMC)
1999/09/24 SUPPL 3 Approval Labeling
1998/04/30 ORIG 1 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
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:AMIODARONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:200MG 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
075135 001 ANDA PACERONE AMIODARONE HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 1998/04/30 UPSHER SMITH LABS
074739 001 ANDA AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 1998/11/30 TEVA PHARMS
075315 001 ANDA AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE TABLET;ORAL 200MG Prescription No Yes AB 1998/12/23 SANDOZ
075389 001 ANDA AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 2001/01/25 MAYNE PHARMA INC
075424 001 ANDA AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 2001/03/30 TARO
077069 001 ANDA AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 2005/04/08 MURTY PHARMS
079029 001 ANDA AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 2008/09/16 ZYDUS PHARMS USA INC
078578 001 ANDA AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 2008/11/06 RUBICON
204742 001 ANDA AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 2016/06/03 AUROBINDO PHARMA LTD
活性成分:AMIODARONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:100MG 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
075424 002 ANDA AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2002/12/18 TARO
075135 002 ANDA PACERONE AMIODARONE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2005/04/12 UPSHER SMITH LABS
077069 003 ANDA AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2016/10/04 MURTY PHARMS
075389 002 ANDA AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2017/12/28 MAYNE PHARMA INC
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