| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| VAPRISOL | 021697 | 001 | NDA | CONIVAPTAN HYDROCHLORIDE | INJECTABLE;INTRAVENOUS | 20MG/4ML (5MG/ML) | No | No | 2005/12/29 | 2005/12/29 | CUMBERLAND | Discontinued |
| VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER | 021697 | 002 | NDA | CONIVAPTAN HYDROCHLORIDE | INJECTABLE;INTRAVENOUS | 20MG/100ML (0.2MG/ML) | Yes | Yes | 2005/12/29 | 2008/10/08 | CUMBERLAND | Prescription |
| VAPRISOL | 022016 | 001 | NDA | CONIVAPTAN HYDROCHLORIDE | INJECTABLE; INJECTION | 20MG | No | No | 2007/02/28 | -- | CUMBERLAND PHARMS | Prescription |
| APRISO | 022301 | 001 | NDA | MESALAMINE | CAPSULE, EXTENDED RELEASE;ORAL | 375MG | Yes | Yes | 2008/10/31 | 2008/10/31 | SALIX | Prescription |