| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ASENAPINE MALEATE | 205960 | 001 | ANDA | ASENAPINE MALEATE | TABLET;SUBLINGUAL | EQ 2.5MG BASE | No | No | 2020/12/10 | 2020/12/10 | BRECKENRIDGE | Prescription |
| ASENAPINE MALEATE | 205960 | 002 | ANDA | ASENAPINE MALEATE | TABLET;SUBLINGUAL | EQ 10MG BASE | No | No | 2020/12/10 | 2020/12/10 | BRECKENRIDGE | Prescription |
| ASENAPINE MALEATE | 205960 | 003 | ANDA | ASENAPINE MALEATE | TABLET;SUBLINGUAL | EQ 5MG BASE | No | No | 2020/12/10 | 2021/03/08 | BRECKENRIDGE | Prescription |
| ASENAPINE MALEATE | 206098 | 001 | ANDA | ASENAPINE MALEATE | TABLET;SUBLINGUAL | EQ 5MG BASE | No | No | 2020/12/10 | 2020/12/10 | ALEMBIC | Prescription |
| ASENAPINE MALEATE | 206098 | 002 | ANDA | ASENAPINE MALEATE | TABLET;SUBLINGUAL | EQ 10MG BASE | No | No | 2020/12/10 | 2020/12/10 | ALEMBIC | Prescription |
| ASENAPINE MALEATE | 206098 | 003 | ANDA | ASENAPINE MALEATE | TABLET;SUBLINGUAL | EQ 2.5MG BASE | No | No | 2020/12/10 | 2021/07/19 | ALEMBIC | Prescription |
| ASENAPINE MALEATE | 206107 | 001 | ANDA | ASENAPINE MALEATE | TABLET;SUBLINGUAL | EQ 5MG BASE | No | No | 2020/12/10 | 2020/12/10 | SIGMAPHARM LABS LLC | Prescription |
| ASENAPINE MALEATE | 206107 | 002 | ANDA | ASENAPINE MALEATE | TABLET;SUBLINGUAL | EQ 10MG BASE | No | No | 2020/12/10 | 2020/12/10 | SIGMAPHARM LABS LLC | Prescription |
| ASENAPINE MALEATE | 205960 | 001 | ANDA | ASENAPINE MALEATE | TABLET;SUBLINGUAL | EQ 2.5MG BASE | No | No | 2021/03/09 | 2020/12/10 | BRECKENRIDGE | Prescription |
| ASENAPINE MALEATE | 205960 | 002 | ANDA | ASENAPINE MALEATE | TABLET;SUBLINGUAL | EQ 10MG BASE | No | No | 2021/03/09 | 2020/12/10 | BRECKENRIDGE | Prescription |
| ASENAPINE MALEATE | 205960 | 003 | ANDA | ASENAPINE MALEATE | TABLET;SUBLINGUAL | EQ 5MG BASE | No | No | 2021/03/09 | 2021/03/08 | BRECKENRIDGE | Prescription |