| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BEPOTASTINE BESILATE | 206080 | 001 | ANDA | BEPOTASTINE BESILATE | SOLUTION;OPHTHALMIC | 1.5% | No | No | 2017/06/07 (TA) | -- | SANDOZ INC | None (Tentative Approval) |
| BEPOTASTINE BESILATE | 206066 | 001 | ANDA | BEPOTASTINE BESILATE | SOLUTION/DROPS;OPHTHALMIC | 1.5% | No | No | 2019/03/05 | 2019/03/05 | APOTEX | Prescription |
| BEPOTASTINE BESILATE | 206220 | 001 | ANDA | BEPOTASTINE BESILATE | SOLUTION/DROPS;OPHTHALMIC | 1.5% | No | No | 2019/03/18 | 2019/03/18 | MYLAN | Prescription |
| BEPOTASTINE BESILATE | 214588 | 001 | ANDA | BEPOTASTINE BESILATE | SOLUTION/DROPS;OPHTHALMIC | 1.5% | No | No | 2023/04/05 | 2023/04/05 | ALEMBIC | Prescription |
| BEPOTASTINE BESILATE | 217770 | 001 | ANDA | BEPOTASTINE BESILATE | SOLUTION/DROPS;OPHTHALMIC | 1.5% | No | No | 2024/08/14 | 2024/08/14 | SOMERSET THERAPS LLC | Prescription |