药品注册申请号:074739
申请类型:ANDA (仿制药申请)
申请人:TEVA PHARMS
申请人全名:TEVA PHARMACEUTICALS USA
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 AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE TABLET;ORAL 200MG No No AB 1998/11/30 1998/11/30 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
2015/09/24 SUPPL 34 Approval Labeling STANDARD
2015/04/06 SUPPL 33 Approval Labeling STANDARD
2015/04/06 SUPPL 32 Approval Labeling STANDARD
2013/05/31 SUPPL 30 Approval Labeling
2011/03/22 SUPPL 27 Approval Labeling
2010/01/08 SUPPL 26 Approval Labeling
2009/07/22 SUPPL 25 Approval Labeling
2009/01/16 SUPPL 24 Approval Labeling
2008/07/14 SUPPL 23 Approval Labeling
2008/03/12 SUPPL 22 Approval Labeling
2007/08/30 SUPPL 21 Approval Labeling
2007/04/30 SUPPL 20 Approval Labeling
2006/08/07 SUPPL 19 Approval Labeling
2006/04/04 SUPPL 18 Approval Labeling
2005/05/11 SUPPL 15 Approval Labeling
2002/05/24 SUPPL 13 Approval Labeling
2001/04/11 SUPPL 12 Approval Manufacturing (CMC)
2001/04/11 SUPPL 11 Approval Manufacturing (CMC)
2000/12/07 SUPPL 10 Approval Manufacturing (CMC)
2000/12/07 SUPPL 9 Approval Manufacturing (CMC)
2000/12/07 SUPPL 8 Approval Manufacturing (CMC)
2000/02/29 SUPPL 7 Approval Labeling
1999/10/26 SUPPL 5 Approval Manufacturing (CMC)
1999/09/02 SUPPL 3 Approval Labeling
1999/09/02 SUPPL 2 Approval Manufacturing (CMC)
1999/09/02 SUPPL 1 Approval Manufacturing (CMC)
1999/03/23 SUPPL 4 Approval Manufacturing (CMC)
1998/11/30 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
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