| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| VARENICLINE TARTRATE | 201808 | 001 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 0.5MG BASE | No | No | 2016/12/15 (TA) | -- | WATSON LABS INC | None (Tentative Approval) |
| VARENICLINE TARTRATE | 201808 | 002 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 1MG BASE | No | No | 2016/12/15 (TA) | -- | WATSON LABS INC | None (Tentative Approval) |
| VARENICLINE TARTRATE | 201785 | 001 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 0.5MG BASE | No | No | 2021/08/11 | 2021/08/11 | ENDO OPERATIONS | Prescription |
| VARENICLINE TARTRATE | 201785 | 002 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 1MG BASE | No | Yes | 2021/08/11 | 2021/08/11 | ENDO OPERATIONS | Prescription |
| VARENICLINE TARTRATE | 201962 | 001 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 0.5MG BASE | No | No | 2023/01/25 | 2023/01/25 | APOTEX | Prescription |
| VARENICLINE TARTRATE | 201962 | 002 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 1MG BASE | No | No | 2023/01/25 | 2023/01/25 | APOTEX | Prescription |
| VARENICLINE TARTRATE | 216723 | 001 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 0.5MG BASE | No | No | 2023/06/12 | 2023/06/12 | ZYDUS | Prescription |
| VARENICLINE TARTRATE | 216723 | 002 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 1MG BASE | No | No | 2023/06/12 | 2023/06/12 | ZYDUS | Prescription |
| VARENICLINE TARTRATE | 217151 | 001 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 0.5MG BASE | No | No | 2023/07/25 | 2023/07/25 | MEDLEY PHARMS | Prescription |
| VARENICLINE TARTRATE | 217151 | 002 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 1MG BASE | No | No | 2023/07/25 | 2023/07/25 | MEDLEY PHARMS | Prescription |
| VARENICLINE TARTRATE | 214255 | 001 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 0.5MG BASE | No | No | 2023/08/01 | 2023/08/01 | MANKIND PHARMA | Prescription |
| VARENICLINE TARTRATE | 214255 | 002 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 1MG BASE | No | No | 2023/08/01 | 2023/08/01 | MANKIND PHARMA | Prescription |
| VARENICLINE TARTRATE | 214557 | 001 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 0.5MG BASE | No | No | 2023/08/23 | 2023/08/23 | ALKEM LABS LTD | Prescription |
| VARENICLINE TARTRATE | 214557 | 002 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 1MG BASE | No | No | 2023/08/23 | 2023/08/23 | ALKEM LABS LTD | Prescription |
| VARENICLINE TARTRATE | 214571 | 001 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 0.5MG BASE | No | No | 2023/10/23 | 2023/10/23 | HETERO LABS LTD III | Prescription |
| VARENICLINE TARTRATE | 214571 | 002 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 1MG BASE | No | No | 2023/10/23 | 2023/10/23 | HETERO LABS LTD III | Prescription |
| VARENICLINE TARTRATE | 211862 | 001 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 0.5MG BASE | No | No | 2023/12/04 | 2023/12/04 | LUPIN LTD | Prescription |
| VARENICLINE TARTRATE | 211862 | 002 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 1MG BASE | No | No | 2023/12/04 | 2023/12/04 | LUPIN LTD | Prescription |
| VARENICLINE TARTRATE | 202019 | 001 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 0.5MG BASE | No | No | 2024/02/29 | 2024/02/28 | MYLAN | Prescription |
| VARENICLINE TARTRATE | 202019 | 002 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 1MG BASE | No | No | 2024/02/29 | 2024/02/28 | MYLAN | Prescription |