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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
BETAGAN | 019219 | 002 | NDA | LEVOBUNOLOL HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | 0.5% | Yes | Yes | 1985/12/19 | 1985/12/19 | ALLERGAN | Prescription |
BETAGAN | 019814 | 001 | NDA | LEVOBUNOLOL HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | 0.25% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1989/06/28 | 1989/06/28 | ALLERGAN | Discontinued |