| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| EPINASTINE HYDROCHLORIDE | 090950 | 001 | ANDA | EPINASTINE HYDROCHLORIDE | SOLUTION; OPHTHALMIC | 0.05% | No | No | 2011/01/27 (TA) | -- | SANDOZ | None (Tentative Approval) |
| EPINASTINE HYDROCHLORIDE | 090870 | 001 | ANDA | EPINASTINE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | 0.05% | No | No | 2011/03/14 | 2011/03/14 | BRECKENRIDGE | Prescription |
| EPINASTINE HYDROCHLORIDE | 090919 | 001 | ANDA | EPINASTINE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | 0.05% | No | No | 2011/10/31 | 2011/10/31 | APOTEX | Prescription |
| EPINASTINE HYDROCHLORIDE | 090951 | 001 | ANDA | EPINASTINE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | 0.05% | No | Yes | 2011/10/31 | 2011/10/31 | SOMERSET THERAPS LLC | Prescription |
| EPINASTINE HYDROCHLORIDE | 091626 | 001 | ANDA | EPINASTINE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | 0.05% | No | No | 2011/10/31 | 2011/10/31 | SUN PHARM INDS | Discontinued |
| EPINASTINE HYDROCHLORIDE | 203384 | 001 | ANDA | EPINASTINE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | 0.05% | No | No | 2016/12/07 | 2016/12/07 | CHARTWELL RX | Discontinued |
| EPINASTINE HYDROCHLORIDE | 204055 | 001 | ANDA | EPINASTINE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | 0.05% | No | No | 2017/05/05 | 2017/05/05 | EPIC PHARMA LLC | Discontinued |