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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
ORTHO-NOVUM 10/11-21 | 018354 | 001 | NDA | ETHINYL ESTRADIOL; NORETHINDRONE | TABLET;ORAL-21 | 0.035MG,0.035MG;0.5MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1982/01/11 | 1982/01/11 | ORTHO MCNEIL JANSSEN | Discontinued |