| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PROMACTA | 022291 | 001 | NDA | ELTROMBOPAG OLAMINE | TABLET;ORAL | EQ 25MG ACID | Yes | No | 2008/11/20 | 2008/11/20 | NOVARTIS | Prescription |
| PROMACTA | 022291 | 002 | NDA | ELTROMBOPAG OLAMINE | TABLET;ORAL | EQ 50MG ACID | Yes | No | 2008/11/20 | 2008/11/20 | NOVARTIS | Prescription |
| PROMACTA | 022291 | 003 | NDA | ELTROMBOPAG OLAMINE | TABLET;ORAL | EQ 75MG ACID | Yes | Yes | 2008/11/20 | 2009/09/08 | NOVARTIS | Prescription |
| PROMACTA | 022291 | 004 | NDA | ELTROMBOPAG OLAMINE | TABLET;ORAL | EQ 12.5MG ACID | Yes | No | 2008/11/20 | 2011/10/20 | NOVARTIS | Prescription |
| PROMACTA | 022291 | 005 | NDA | ELTROMBOPAG OLAMINE | TABLET;ORAL | EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2008/11/20 | 2012/11/16 | NOVARTIS | Discontinued |
| PROMACTA KIT | 207027 | 001 | NDA | ELTROMBOPAG OLAMINE | FOR SUSPENSION;ORAL | EQ 25MG ACID/PACKET | Yes | Yes | 2015/08/24 | 2015/08/24 | NOVARTIS | Prescription |
| PROMACTA KIT | 207027 | 002 | NDA | ELTROMBOPAG OLAMINE | FOR SUSPENSION;ORAL | EQ 12.5MG ACID/PACKET | Yes | No | 2015/08/24 | 2018/09/27 | NOVARTIS | Prescription |