| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TAXOTERE | 020449 | 001 | NDA | DOCETAXEL | INJECTABLE;INJECTION | 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1996/05/14 | 1996/05/14 | SANOFI AVENTIS US | Discontinued |
| TAXOTERE | 020449 | 003 | NDA | DOCETAXEL | INJECTABLE;INJECTION | 20MG/ML (20MG/ML) | Yes | Yes | 1996/05/14 | 2010/08/03 | SANOFI AVENTIS US | Prescription |
| TAXOTERE | 020449 | 004 | NDA | DOCETAXEL | INJECTABLE;INJECTION | 80MG/4ML (20MG/ML) | Yes | Yes | 1996/05/14 | 2010/08/02 | SANOFI AVENTIS US | Prescription |
| TAXOTERE | 020449 | 005 | NDA | DOCETAXEL | INJECTABLE;INJECTION | 160MG/8ML (20MG/ML) | Yes | Yes | 1996/05/14 | 2012/04/13 | SANOFI AVENTIS US | Prescription |