| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ZOLPIDEM TARTRATE | 204299 | 001 | ANDA | ZOLPIDEM TARTRATE | TABLET;SUBLINGUAL | 1.75MG | No | No | 2015/06/03 | 2015/06/03 | NOVEL LABS INC | Prescription |
| ZOLPIDEM TARTRATE | 204299 | 002 | ANDA | ZOLPIDEM TARTRATE | TABLET;SUBLINGUAL | 3.5MG | No | Yes | 2015/06/03 | 2015/06/03 | NOVEL LABS INC | Prescription |
| ZOLPIDEM TARTRATE | 201509 | 001 | ANDA | ZOLPIDEM TARTRATE | TABLET;SUBLINGUAL | 5MG | No | No | 2016/08/01 | 2016/08/01 | ENDO OPERATIONS | Prescription |
| ZOLPIDEM TARTRATE | 201509 | 002 | ANDA | ZOLPIDEM TARTRATE | TABLET;SUBLINGUAL | 10MG | No | No | 2016/08/01 | 2016/08/01 | ENDO OPERATIONS | Prescription |
| ZOLPIDEM TARTRATE | 202657 | 001 | ANDA | ZOLPIDEM TARTRATE | TABLET;SUBLINGUAL | 5MG | No | No | 2016/08/08 | 2016/08/08 | NORVIUM BIOSCIENCE | Discontinued |
| ZOLPIDEM TARTRATE | 202657 | 002 | ANDA | ZOLPIDEM TARTRATE | TABLET;SUBLINGUAL | 10MG | No | No | 2016/08/08 | 2016/08/08 | NORVIUM BIOSCIENCE | Discontinued |
| ZOLPIDEM TARTRATE | 204503 | 001 | ANDA | ZOLPIDEM TARTRATE | TABLET;SUBLINGUAL | 1.75MG | No | No | 2016/11/18 | 2016/11/18 | DR REDDYS | Prescription |
| ZOLPIDEM TARTRATE | 204503 | 002 | ANDA | ZOLPIDEM TARTRATE | TABLET;SUBLINGUAL | 3.5MG | No | No | 2016/11/18 | 2016/11/18 | DR REDDYS | Prescription |
| ZOLPIDEM TARTRATE | 204170 | 001 | ANDA | ZOLPIDEM TARTRATE | TABLET, EXTENDED RELEASE;ORAL | 6.25MG | No | No | 2017/01/24 | 2017/01/24 | SUN PHARM | Prescription |
| ZOLPIDEM TARTRATE | 204170 | 002 | ANDA | ZOLPIDEM TARTRATE | TABLET, EXTENDED RELEASE;ORAL | 12.5MG | No | No | 2017/01/24 | 2017/01/24 | SUN PHARM | Prescription |
| ZOLPIDEM TARTRATE | 204229 | 001 | ANDA | ZOLPIDEM TARTRATE | TABLET;SUBLINGUAL | 1.75MG | No | No | 2017/09/11 | 2017/09/11 | ENDO OPERATIONS | Prescription |
| ZOLPIDEM TARTRATE | 204229 | 002 | ANDA | ZOLPIDEM TARTRATE | TABLET;SUBLINGUAL | 3.5MG | No | No | 2017/09/11 | 2017/09/11 | ENDO OPERATIONS | Prescription |
| ZOLPIDEM TARTRATE | 213592 | 001 | ANDA | ZOLPIDEM TARTRATE | TABLET, EXTENDED RELEASE;ORAL | 6.25MG | No | No | 2020/06/04 | 2020/06/04 | BRECKENRIDGE | Discontinued |
| ZOLPIDEM TARTRATE | 213592 | 002 | ANDA | ZOLPIDEM TARTRATE | TABLET, EXTENDED RELEASE;ORAL | 12.5MG | No | No | 2020/06/04 | 2020/06/04 | BRECKENRIDGE | Discontinued |
| ZOLPIDEM TARTRATE | 215721 | 001 | NDA | ZOLPIDEM TARTRATE | CAPSULE;ORAL | 7.5MG | Yes | Yes | 2023/05/09 | 2023/05/09 | ALMATICA | Prescription |