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 |
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 |
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 |
关联产品号 | 独占权代码 | 失效日期 | 备注 |
---|---|---|---|
无 |
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 | RLD | RS | TE 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 |