| 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 | 217283 | 001 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 0.5MG BASE | No | No | 2024/03/06 | 2024/03/06 | NE RX PHARMA | Prescription |
| VARENICLINE TARTRATE | 217283 | 002 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 1MG BASE | No | No | 2024/03/06 | 2024/03/06 | NE RX PHARMA | Prescription |
| VARENICLINE TARTRATE | 213019 | 001 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 0.5MG BASE | No | No | 2024/03/19 | 2024/03/19 | AJANTA PHARMA LTD | Prescription |
| VARENICLINE TARTRATE | 213019 | 002 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 1MG BASE | No | No | 2024/03/19 | 2024/03/19 | AJANTA PHARMA LTD | Prescription |
| VARENICLINE TARTRATE | 217115 | 001 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 0.5MG BASE | No | No | 2024/07/23 | 2024/07/23 | PIRAMAL | Discontinued |
| VARENICLINE TARTRATE | 217115 | 002 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 1MG BASE | No | No | 2024/07/23 | 2024/07/23 | PIRAMAL | Discontinued |
| VARENICLINE TARTRATE | 215931 | 001 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 0.5MG BASE | No | No | 2024/10/01 | 2024/10/01 | DR REDDYS | Prescription |
| VARENICLINE TARTRATE | 215931 | 002 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 1MG BASE | No | No | 2024/10/01 | 2024/10/01 | DR REDDYS | Prescription |
| VARENICLINE TARTRATE | 219106 | 001 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 0.5MG BASE | No | No | 2024/10/29 | 2024/10/29 | REGCON HOLDINGS | Prescription |
| VARENICLINE TARTRATE | 219106 | 002 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 1MG BASE | No | No | 2024/10/29 | 2024/10/29 | REGCON HOLDINGS | Prescription |
| VARENICLINE TARTRATE | 215048 | 001 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 0.5MG BASE | No | No | 2024/12/09 | 2024/12/09 | MACLEODS PHARMS LTD | Prescription |
| VARENICLINE TARTRATE | 215048 | 002 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 1MG BASE | No | No | 2024/12/09 | 2024/12/09 | MACLEODS PHARMS LTD | Prescription |
| VARENICLINE TARTRATE | 216615 | 001 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 0.5MG BASE | No | No | 2025/04/08 | 2025/04/08 | SHILPA | Prescription |
| VARENICLINE TARTRATE | 216615 | 002 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 1MG BASE | No | No | 2025/04/08 | 2025/04/08 | SHILPA | Prescription |
| VARENICLINE TARTRATE | 214595 | 001 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 0.5MG BASE | No | No | 2025/05/02 | 2025/05/02 | AUROBINDO PHARMA | Prescription |
| VARENICLINE TARTRATE | 214595 | 002 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 1MG BASE | No | No | 2025/05/02 | 2025/05/02 | AUROBINDO PHARMA | Prescription |
| VARENICLINE TARTRATE | 212879 | 001 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 0.5MG BASE | No | No | 2025/05/06 | 2025/05/06 | VIWIT PHARM | Prescription |
| VARENICLINE TARTRATE | 212879 | 002 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 1MG BASE | No | No | 2025/05/06 | 2025/05/06 | VIWIT PHARM | Prescription |
| VARENICLINE TARTRATE | 213268 | 001 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 0.5MG BASE | No | No | 2025/05/21 | 2025/05/21 | RHODES PHARMS | Discontinued |
| VARENICLINE TARTRATE | 213268 | 002 | ANDA | VARENICLINE TARTRATE | TABLET;ORAL | EQ 1MG BASE | No | No | 2025/05/21 | 2025/05/21 | RHODES PHARMS | Discontinued |