药品注册审批历史信息 |
申请号 | 修订号 | 审批结论 | 审批日期 | 审批内容 |
205834 | 015 | AP | 2016/10/11 | Manufacturing Change or Addition |
205834 | 013 | AP | 2016/09/29 | Manufacturing Change or Addition |
205834 | 012 | AP | 2016/06/22 | Manufacturing Change or Addition |
205834 | 011 | AP | 2016/02/17 | Labeling Revision |
205834 | 010 | AP | 2016/06/08 | Labeling Revision |
205834 | 009 | AP | 2016/02/12 | Efficacy Supplement with Clinical Data to Support |
205834 | 008 | AP | 2016/02/12 | Efficacy Supplement with Clinical Data to Support |
205834 | 007 | AP | 2016/02/12 | Patient Population Altered |
205834 | 006 | AP | 2015/11/12 | Efficacy Supplement with Clinical Data to Support |
205834 | 005 | AP | 2015/11/12 | Efficacy Supplement with Clinical Data to Support |
205834 | 004 | AP | 2015/11/12 | Efficacy Supplement with Clinical Data to Support |
205834 | 003 | AP | 2015/11/12 | Efficacy Supplement with Clinical Data to Support |
205834 | 002 | AP | 2015/11/12 | Efficacy Supplement with Clinical Data to Support |
205834 | 001 | AP | 2015/03/20 | Labeling Revision |
205834 | 000 | AP | 2014/10/10 | Approval |