| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BACLOFEN | 210777 | 001 | ANDA | BACLOFEN | INJECTABLE;INTRATHECAL | 0.05MG/ML | No | No | 2021/01/15 | 2021/01/15 | MAIA PHARMS INC | Prescription |
| BACLOFEN | 214374 | 001 | ANDA | BACLOFEN | TABLET;ORAL | 5MG | No | No | 2021/03/05 | 2021/03/05 | RISING | Prescription |
| BACLOFEN | 214374 | 002 | ANDA | BACLOFEN | TABLET;ORAL | 10MG | No | No | 2021/03/05 | 2021/03/05 | RISING | Prescription |
| BACLOFEN | 214374 | 003 | ANDA | BACLOFEN | TABLET;ORAL | 20MG | No | No | 2021/03/05 | 2021/03/05 | RISING | Prescription |
| BACLOFEN | 214099 | 001 | ANDA | BACLOFEN | TABLET;ORAL | 10MG | No | No | 2021/07/13 | 2021/07/13 | AUROBINDO PHARMA LTD | Prescription |
| BACLOFEN | 214099 | 002 | ANDA | BACLOFEN | TABLET;ORAL | 20MG | No | No | 2021/07/13 | 2021/07/13 | AUROBINDO PHARMA LTD | Prescription |
| BACLOFEN | 214114 | 001 | ANDA | BACLOFEN | TABLET;ORAL | 10MG | No | No | 2021/07/16 | 2021/07/16 | BEXIMCO PHARMS USA | Prescription |
| BACLOFEN | 214114 | 002 | ANDA | BACLOFEN | TABLET;ORAL | 20MG | No | No | 2021/07/16 | 2021/07/16 | BEXIMCO PHARMS USA | Prescription |
| BACLOFEN | 214114 | 003 | ANDA | BACLOFEN | TABLET;ORAL | 5MG | No | No | 2021/07/16 | 2023/09/19 | BEXIMCO PHARMS USA | Prescription |
| BACLOFEN | 215885 | 001 | ANDA | BACLOFEN | TABLET;ORAL | 5MG | No | No | 2022/01/25 | 2022/01/25 | MANKIND PHARMA | Prescription |
| BACLOFEN | 215885 | 002 | ANDA | BACLOFEN | TABLET;ORAL | 10MG | No | No | 2022/01/25 | 2022/01/25 | MANKIND PHARMA | Prescription |
| BACLOFEN | 215885 | 003 | ANDA | BACLOFEN | TABLET;ORAL | 20MG | No | No | 2022/01/25 | 2022/01/25 | MANKIND PHARMA | Prescription |
| BACLOFEN | 217324 | 001 | ANDA | BACLOFEN | INJECTABLE;INTRATHECAL | 0.5MG/ML | No | No | 2023/02/22 | 2023/02/22 | RUBICON | Prescription |
| BACLOFEN | 217324 | 002 | ANDA | BACLOFEN | INJECTABLE;INTRATHECAL | 1MG/ML | No | No | 2023/02/22 | 2023/02/22 | RUBICON | Prescription |
| BACLOFEN | 217324 | 003 | ANDA | BACLOFEN | INJECTABLE;INTRATHECAL | 2MG/ML | No | No | 2023/02/22 | 2023/02/22 | RUBICON | Prescription |
| BACLOFEN | 214445 | 001 | ANDA | BACLOFEN | SOLUTION;ORAL | 5MG/5ML | No | No | 2023/03/13 (TA) | -- | RUBICON | None (Tentative Approval) |
| BACLOFEN | 217252 | 001 | ANDA | BACLOFEN | SUSPENSION;ORAL | 25MG/5ML | No | No | 2023/06/08 | 2023/06/08 | ANI PHARMS | Prescription |
| BACLOFEN | 216309 | 001 | ANDA | BACLOFEN | INJECTABLE;INTRATHECAL | 0.5MG/ML | No | No | 2023/08/10 | 2023/08/10 | ACIC PHARMS | Discontinued |
| BACLOFEN | 216309 | 002 | ANDA | BACLOFEN | INJECTABLE;INTRATHECAL | 2MG/ML | No | No | 2023/08/10 | 2023/08/10 | ACIC PHARMS | Discontinued |
| BACLOFEN | 217687 | 001 | ANDA | BACLOFEN | TABLET;ORAL | 5MG | No | No | 2023/11/08 | 2023/11/08 | MICRO LABS | Prescription |