| 商品名 | 申请号 | 产品号 | 申请类型 | 活性成分 | 剂型/给药途径 | 规格/剂量 | RLD | RS | 申请号原始批准/暂定批准日期 | 产品号批准日期 | 申请人 | 市场状态 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BYDUREON | 022200 | 001 | NDA | EXENATIDE SYNTHETIC | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 2MG/VIAL | Yes | No | 2012/01/27 | 2012/01/27 | ASTRAZENECA AB | Discontinued |
| BYDUREON PEN | 022200 | 002 | NDA | EXENATIDE SYNTHETIC | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 2MG | Yes | No | 2012/01/27 | 2014/02/28 | ASTRAZENECA AB | Discontinued |
| BYDUREON BCISE | 209210 | 001 | NDA | EXENATIDE SYNTHETIC | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 2MG/0.85ML (2MG/0.85ML) | Yes | Yes | 2017/10/20 | 2017/10/20 | ASTRAZENECA AB | Prescription |