| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CYCLOGYL | 084108 | 001 | ANDA | CYCLOPENTOLATE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | 2% | Yes | Yes | 1974/07/31 | Approved Prior to Jan 1, 1982 | ALCON LABS INC | Prescription |
| CYCLOGYL | 084109 | 001 | ANDA | CYCLOPENTOLATE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | 0.5% | Yes | Yes | 1974/07/31 | Approved Prior to Jan 1, 1982 | ALCON LABS INC | Prescription |
| CYCLOGYL | 084110 | 001 | ANDA | CYCLOPENTOLATE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | 1% | Yes | Yes | 1974/07/31 | Approved Prior to Jan 1, 1982 | ALCON LABS INC | Prescription |