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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
ZEMPLAR | 020819 | 001 | NDA | PARICALCITOL | SOLUTION;INTRAVENOUS | 0.005MG/ML (0.005MG/ML) | Yes | Yes | 1998/04/17 | 1998/04/17 | ABBVIE | Prescription |
ZEMPLAR | 020819 | 002 | NDA | PARICALCITOL | SOLUTION;INTRAVENOUS | 0.002MG/ML (0.002MG/ML) | Yes | Yes | 1998/04/17 | 2000/02/01 | ABBVIE | Prescription |
ZEMPLAR | 020819 | 003 | NDA | PARICALCITOL | SOLUTION;INTRAVENOUS | 0.01MG/2ML (0.005MG/ML) | Yes | Yes | 1998/04/17 | 2000/02/01 | ABBVIE | Prescription |
ZEMPLAR | 021606 | 001 | NDA | PARICALCITOL | CAPSULE;ORAL | 1MCG | Yes | No | 2005/05/26 | 2005/05/26 | ABBVIE | Prescription |
ZEMPLAR | 021606 | 002 | NDA | PARICALCITOL | CAPSULE;ORAL | 2MCG | Yes | No | 2005/05/26 | 2005/05/26 | ABBVIE | Prescription |
ZEMPLAR | 021606 | 003 | NDA | PARICALCITOL | CAPSULE;ORAL | 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2005/05/26 | 2005/05/26 | ABBVIE | Discontinued |