| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| LURASIDONE HYDROCHLORIDE | 207948 | 001 | ANDA | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 20MG | No | No | 2017/05/19 (TA) | -- | PAR PHARM INC | None (Tentative Approval) |
| LURASIDONE HYDROCHLORIDE | 207948 | 002 | ANDA | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 40MG | No | No | 2017/05/19 (TA) | -- | PAR PHARM INC | None (Tentative Approval) |
| LURASIDONE HYDROCHLORIDE | 207948 | 003 | ANDA | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 60MG | No | No | 2017/05/19 (TA) | -- | PAR PHARM INC | None (Tentative Approval) |
| LURASIDONE HYDROCHLORIDE | 207948 | 004 | ANDA | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 80MG | No | No | 2017/05/19 (TA) | -- | PAR PHARM INC | None (Tentative Approval) |
| LURASIDONE HYDROCHLORIDE | 207948 | 005 | ANDA | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 120MG | No | No | 2017/05/19 (TA) | -- | PAR PHARM INC | None (Tentative Approval) |
| LURASIDONE HYDROCHLORIDE | 208002 | 001 | ANDA | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 20MG | No | No | 2019/01/03 | 2019/01/03 | AMNEAL PHARMS CO | Prescription |
| LURASIDONE HYDROCHLORIDE | 208002 | 002 | ANDA | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 40MG | No | No | 2019/01/03 | 2019/01/03 | AMNEAL PHARMS CO | Prescription |
| LURASIDONE HYDROCHLORIDE | 208002 | 003 | ANDA | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 60MG | No | No | 2019/01/03 | 2019/01/03 | AMNEAL PHARMS CO | Prescription |
| LURASIDONE HYDROCHLORIDE | 208002 | 004 | ANDA | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 80MG | No | No | 2019/01/03 | 2019/01/03 | AMNEAL PHARMS CO | Prescription |
| LURASIDONE HYDROCHLORIDE | 208002 | 005 | ANDA | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 120MG | No | No | 2019/01/03 | 2019/01/03 | AMNEAL PHARMS CO | Prescription |
| LURASIDONE HYDROCHLORIDE | 208028 | 001 | ANDA | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 20MG | No | No | 2019/01/03 | 2019/01/03 | INVAGEN PHARMS | Prescription |
| LURASIDONE HYDROCHLORIDE | 208028 | 002 | ANDA | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 40MG | No | No | 2019/01/03 | 2019/01/03 | INVAGEN PHARMS | Prescription |
| LURASIDONE HYDROCHLORIDE | 208028 | 003 | ANDA | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 60MG | No | No | 2019/01/03 | 2019/01/03 | INVAGEN PHARMS | Prescription |
| LURASIDONE HYDROCHLORIDE | 208028 | 004 | ANDA | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 80MG | No | No | 2019/01/03 | 2019/01/03 | INVAGEN PHARMS | Prescription |
| LURASIDONE HYDROCHLORIDE | 208028 | 005 | ANDA | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 120MG | No | No | 2019/01/03 | 2019/01/03 | INVAGEN PHARMS | Prescription |
| LURASIDONE HYDROCHLORIDE | 208031 | 001 | ANDA | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 20MG | No | No | 2019/01/03 | 2019/01/03 | LUPIN LTD | Prescription |
| LURASIDONE HYDROCHLORIDE | 208031 | 002 | ANDA | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 40MG | No | No | 2019/01/03 | 2019/01/03 | LUPIN LTD | Prescription |
| LURASIDONE HYDROCHLORIDE | 208031 | 003 | ANDA | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 60MG | No | No | 2019/01/03 | 2019/01/03 | LUPIN LTD | Prescription |
| LURASIDONE HYDROCHLORIDE | 208031 | 004 | ANDA | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 80MG | No | No | 2019/01/03 | 2019/01/03 | LUPIN LTD | Prescription |
| LURASIDONE HYDROCHLORIDE | 208031 | 005 | ANDA | LURASIDONE HYDROCHLORIDE | TABLET;ORAL | 120MG | No | No | 2019/01/03 | 2019/01/03 | LUPIN LTD | Prescription |