| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ORKAMBI | 206038 | 001 | NDA | IVACAFTOR; LUMACAFTOR | TABLET;ORAL | 125MG;200MG | Yes | Yes | 2015/07/02 | 2015/07/02 | VERTEX PHARMS INC | Prescription |
| ORKAMBI | 206038 | 002 | NDA | IVACAFTOR; LUMACAFTOR | TABLET;ORAL | 125MG;100MG | Yes | No | 2015/07/02 | 2016/09/28 | VERTEX PHARMS INC | Prescription |
| ORKAMBI | 211358 | 001 | NDA | IVACAFTOR; LUMACAFTOR | GRANULE;ORAL | 125MG/PACKET;100MG/PACKET | Yes | No | 2018/08/07 | 2018/08/07 | VERTEX PHARMS INC | Prescription |
| ORKAMBI | 211358 | 002 | NDA | IVACAFTOR; LUMACAFTOR | GRANULE;ORAL | 188MG/PACKET;150MG/PACKET | Yes | Yes | 2018/08/07 | 2018/08/07 | VERTEX PHARMS INC | Prescription |
| ORKAMBI | 211358 | 003 | NDA | IVACAFTOR; LUMACAFTOR | GRANULE;ORAL | 94MG/PACKET;75MG/PACKET | Yes | No | 2018/08/07 | 2022/09/02 | VERTEX PHARMS INC | Prescription |