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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
DIDRONEL | 017831 | 001 | NDA | ETIDRONATE DISODIUM | TABLET;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1977/09/01 | Approved Prior to Jan 1, 1982 | APIL | Discontinued |
DIDRONEL | 017831 | 002 | NDA | ETIDRONATE DISODIUM | TABLET;ORAL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1977/09/01 | Approved Prior to Jan 1, 1982 | APIL | Discontinued |
DIDRONEL | 019545 | 001 | NDA | ETIDRONATE DISODIUM | INJECTABLE;INJECTION | 50MG/ML | No | No | 1987/04/20 | 1987/04/20 | MGI PHARMA INC | Discontinued |