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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
OVULEN | 016029 | 002 | NDA | ETHYNODIOL DIACETATE; MESTRANOL | TABLET;ORAL-20 | 1MG;0.1MG | No | No | 1966/03/23 | Approved Prior to Jan 1, 1982 | GD SEARLE LLC | Discontinued |
OVULEN-21 | 016029 | 003 | NDA | ETHYNODIOL DIACETATE; MESTRANOL | TABLET;ORAL-21 | 1MG;0.1MG | No | No | 1966/03/23 | Approved Prior to Jan 1, 1982 | GD SEARLE LLC | Discontinued |
OVULEN-28 | 016705 | 001 | NDA | ETHYNODIOL DIACETATE; MESTRANOL | TABLET;ORAL-28 | 1MG;0.1MG | No | No | 1967/10/02 | Approved Prior to Jan 1, 1982 | GD SEARLE LLC | Discontinued |