| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ZOMETA | 021223 | 001 | NDA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2001/08/20 | 2001/08/20 | NOVARTIS | Discontinued |
| ZOMETA | 021223 | 002 | NDA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 4MG BASE/5ML | Yes | No | 2001/08/20 | 2003/03/07 | NOVARTIS | Discontinued |
| ZOMETA | 021223 | 003 | NDA | ZOLEDRONIC ACID | INJECTABLE;INTRAVENOUS | EQ 4MG BASE/100ML | Yes | No | 2001/08/20 | 2011/06/17 | NOVARTIS | Discontinued |
| ZOMETA | 021386 | 001 | NDA | ZOLEDRONIC ACID | INJECTABLE; IV (INFUSION) | EQ 4MG BASE/VIAL | No | No | 2002/02/22 | -- | NOVARTIS | Prescription |