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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
MIACALCIN | 017808 | 001 | NDA | CALCITONIN SALMON | INJECTABLE;INJECTION | 100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1986/07/03 | 1986/07/03 | MYLAN IRELAND LTD | Discontinued |
MIACALCIN | 017808 | 002 | NDA | CALCITONIN SALMON | INJECTABLE;INJECTION | 200 IU/ML | Yes | Yes | 1986/07/03 | 1991/03/29 | MYLAN IRELAND LTD | Prescription |
MIACALCIN | 020313 | 002 | NDA | CALCITONIN SALMON | SPRAY, METERED;NASAL | 200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1995/08/17 | 1995/08/17 | NORVIUM BIOSCIENCE | Discontinued |