| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| LUMATEPERONE | 219085 | 002 | ANDA | LUMATEPERONE | CAPSULE | 42MG | No | No | 2025/03/26 (TA) | -- | AUROBINDO PHARMA LIMITED | None (Tentative Approval) |
| LUMATEPERONE | 219085 | 003 | ANDA | LUMATEPERONE | CAPSULE | 28MG | No | No | 2025/03/26 (TA) | -- | AUROBINDO PHARMA LIMITED | None (Tentative Approval) |
| LUMATEPERONE | 219085 | 004 | ANDA | LUMATEPERONE | CAPSULE | 10.5MG | No | No | 2025/03/26 (TA) | -- | AUROBINDO PHARMA LIMITED | None (Tentative Approval) |
| LUMATEPERONE | 219085 | 005 | ANDA | LUMATEPERONE | CAPSULE | 21MG | No | No | 2025/03/26 (TA) | -- | AUROBINDO PHARMA LIMITED | None (Tentative Approval) |
| LUMATEPERONE TOSYLATE | 219248 | 001 | ANDA | LUMATEPERONE TOSYLATE | CAPSULE | 10.5MG | No | No | 2025/05/01 (TA) | -- | MSN LABORATORIES PRIVATE LTD | None (Tentative Approval) |
| LUMATEPERONE TOSYLATE | 219248 | 002 | ANDA | LUMATEPERONE TOSYLATE | CAPSULE | 14MG | No | No | 2025/05/01 (TA) | -- | MSN LABORATORIES PRIVATE LTD | None (Tentative Approval) |
| LUMATEPERONE TOSYLATE | 219248 | 003 | ANDA | LUMATEPERONE TOSYLATE | CAPSULE | 21MG | No | No | 2025/05/01 (TA) | -- | MSN LABORATORIES PRIVATE LTD | None (Tentative Approval) |
| LUMATEPERONE TOSYLATE | 219248 | 004 | ANDA | LUMATEPERONE TOSYLATE | CAPSULE | 28MG | No | No | 2025/05/01 (TA) | -- | MSN LABORATORIES PRIVATE LTD | None (Tentative Approval) |
| LUMATEPERONE TOSYLATE | 219248 | 005 | ANDA | LUMATEPERONE TOSYLATE | CAPSULE | 42MG | No | No | 2025/05/01 (TA) | -- | MSN LABORATORIES PRIVATE LTD | None (Tentative Approval) |
| LUMATEPERONE TOSYLATE | 219142 | 002 | ANDA | LUMATEPERONE TOSYLATE | CAPSULE | 14MG | No | No | 2025/05/19 (TA) | -- | HETERO LABS LIMITED | None (Tentative Approval) |
| LUMATEPERONE TOSYLATE | 219142 | 003 | ANDA | LUMATEPERONE TOSYLATE | CAPSULE | 21MG | No | No | 2025/05/19 (TA) | -- | HETERO LABS LIMITED | None (Tentative Approval) |
| LUMATEPERONE TOSYLATE | 219142 | 004 | ANDA | LUMATEPERONE TOSYLATE | CAPSULE | 28MG | No | No | 2025/05/19 (TA) | -- | HETERO LABS LIMITED | None (Tentative Approval) |
| LUMATEPERONE TOSYLATE | 219142 | 005 | ANDA | LUMATEPERONE TOSYLATE | CAPSULE | 42MG | No | No | 2025/05/19 (TA) | -- | HETERO LABS LIMITED | None (Tentative Approval) |
| LUMATEPERONE | 219200 | 002 | ANDA | LUMATEPERONE | CAPSULE | 42MG | No | No | 2025/05/27 (TA) | -- | ALKEM LABS LTD | None (Tentative Approval) |
| LUMATEPERONE | 219200 | 003 | ANDA | LUMATEPERONE | CAPSULE | 28MG | No | No | 2025/05/27 (TA) | -- | ALKEM LABS LTD | None (Tentative Approval) |
| LUMATEPERONE | 219200 | 004 | ANDA | LUMATEPERONE | CAPSULE | 10.5MG | No | No | 2025/05/27 (TA) | -- | ALKEM LABS LTD | None (Tentative Approval) |
| LUMATEPERONE | 219200 | 005 | ANDA | LUMATEPERONE | CAPSULE | 21MG | No | No | 2025/05/27 (TA) | -- | ALKEM LABS LTD | None (Tentative Approval) |
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