| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| LO/OVRAL | 017612 | 001 | NDA | ETHINYL ESTRADIOL; NORGESTREL | TABLET;ORAL-21 | 0.03MG;0.3MG | Yes | No | 1975/03/17 | Approved Prior to Jan 1, 1982 | CADENCE HEALTH | Discontinued |
| LO/OVRAL-28 | 017802 | 001 | NDA | ETHINYL ESTRADIOL; NORGESTREL | TABLET;ORAL-28 | 0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1976/03/16 | Approved Prior to Jan 1, 1982 | WYETH PHARMS | Discontinued |
| LO/OVRAL FE | 018206 | 001 | NDA | ETHINYL ESTRADIOL; LEVONORGESTREL; FERROUS FUMARATE | TABLET;ORAL | 0.03MG,0.3MG;75MG | No | No | 1979/07/26 | -- | CADENCE HEALTH | Prescription |