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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
AREDIA | 020036 | 001 | NDA | PAMIDRONATE DISODIUM | INJECTABLE;INJECTION | 30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1991/10/31 | 1991/10/31 | NOVARTIS | Discontinued |
AREDIA | 020036 | 003 | NDA | PAMIDRONATE DISODIUM | INJECTABLE;INJECTION | 60MG/VIAL | No | No | 1991/10/31 | 1993/05/06 | NOVARTIS | Discontinued |
AREDIA | 020036 | 004 | NDA | PAMIDRONATE DISODIUM | INJECTABLE;INJECTION | 90MG/VIAL | No | No | 1991/10/31 | 1993/05/06 | NOVARTIS | Discontinued |
AREDIA | 020927 | 001 | NDA | PAMIDRONATE DISODIUM | INJECTABLE; INJECTION | 30MG/VIAL | No | No | 1998/09/22 | -- | NOVARTIS | Prescription |
AREDIA | 020927 | 002 | NDA | PAMIDRONATE DISODIUM | INJECTABLE;INJECTION | 60MG/VIAL | No | No | 1998/09/22 | -- | NOVARTIS | Prescription |
AREDIA | 020927 | 003 | NDA | PAMIDRONATE DISODIUM | INJECTABLE; INJECTION | 90MG/VIAL | No | No | 1998/09/22 | -- | NOVARTIS | Prescription |