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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
NOLVADEX | 017970 | 001 | NDA | TAMOXIFEN CITRATE | TABLET;ORAL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1977/12/30 | Approved Prior to Jan 1, 1982 | ASTRAZENECA | Discontinued |
NOLVADEX | 017970 | 002 | NDA | TAMOXIFEN CITRATE | TABLET;ORAL | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1977/12/30 | 1994/03/21 | ASTRAZENECA | Discontinued |