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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
VAGIFEM | 020908 | 001 | NDA | ESTRADIOL | TABLET;VAGINAL | 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1999/03/26 | 1999/03/26 | NOVO NORDISK INC | Discontinued |
VAGIFEM | 020908 | 002 | NDA | ESTRADIOL | TABLET;VAGINAL | 10MCG | Yes | Yes | 1999/03/26 | 2009/11/25 | NOVO NORDISK INC | Prescription |