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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
FEMHRT | 021065 | 001 | NDA | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | TABLET;ORAL | 0.0025MG;0.5MG | Yes | No | 1999/10/15 | 2005/01/14 | APIL | Discontinued |
FEMHRT | 021065 | 002 | NDA | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | TABLET;ORAL | 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1999/10/15 | 1999/10/15 | APIL | Discontinued |
FEMHRT | 021102 | 001 | NDA | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | TABLET; ORAL | 0.005MG;1MG | No | No | 1999/10/15 | -- | WARNER CHILCOTT | Prescription |