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 |
