| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NALTREXONE HYDROCHLORIDE | 074918 | 001 | ANDA | NALTREXONE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No | 1998/05/08 | 1998/05/08 | BARR | Prescription |
| NALTREXONE HYDROCHLORIDE | 075274 | 001 | ANDA | NALTREXONE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No | 1999/05/26 | 1999/05/26 | ELITE LABS | Prescription |
| NALTREXONE HYDROCHLORIDE | 075434 | 001 | ANDA | NALTREXONE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No | 2000/03/08 | 2000/03/08 | FOSUN PHARMA | Discontinued |
| NALTREXONE HYDROCHLORIDE | 076264 | 001 | ANDA | NALTREXONE HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No | 2002/03/22 | 2002/03/22 | SPECGX LLC | Prescription |
| NALTREXONE HYDROCHLORIDE | 076264 | 002 | ANDA | NALTREXONE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | Yes | 2002/03/22 | 2002/03/22 | SPECGX LLC | Prescription |
| NALTREXONE HYDROCHLORIDE | 076264 | 003 | ANDA | NALTREXONE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No | 2002/03/22 | 2002/03/22 | SPECGX LLC | Prescription |
| NALTREXONE HYDROCHLORIDE | 091205 | 001 | ANDA | NALTREXONE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No | 2011/08/17 | 2011/08/17 | ACCORD HLTHCARE | Prescription |
| NALTREXONE HYDROCHLORIDE | 090356 | 001 | ANDA | NALTREXONE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No | 2012/02/24 | 2012/02/24 | SUN PHARM | Prescription |
| METHYLNALTREXONE BROMIDE | 208592 | 001 | ANDA | METHYLNALTREXONE BROMIDE | INJECTABLE;SUBCUTANEOUS | 12MG/0.6ML | No | No | 2017/05/03 (TA) | -- | MYLAN LABS LTD | None (Tentative Approval) |
| NALTREXONE HYDROCHLORIDE | 207905 | 001 | ANDA | NALTREXONE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No | 2017/07/21 | 2017/07/21 | CHARTWELL | Prescription |
| METHYLNALTREXONE BROMIDE | 208038 | 001 | ANDA | METHYLNALTREXONE BROMIDE | SOLUTION;SUBCUTANEOUS | 12MG/0.6ML | No | No | 2021/08/12 (TA) | -- | US GENERICS, STERILES | None (Tentative Approval) |
| NALTREXONE HYDROCHLORIDE; BUPROPION HYDROCHLORIDE | 208043 | 001 | ANDA | NALTREXONE HYDROCHLORIDE;BUPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | 8MG/90MG | No | No | 2022/11/29 (TA) | -- | ACTAVIS LABS FL INC | None (Tentative Approval) |
| NALTREXONE | 213195 | 001 | ANDA | NALTREXONE | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 380MG/VIAL | No | No | 2023/07/06 | 2023/07/06 | TEVA PHARMS USA INC | Discontinued |
| METHYLNALTREXONE BROMIDE | 208112 | 001 | ANDA | METHYLNALTREXONE BROMIDE | SOLUTION;SUBCUTANEOUS | 8MG/0.4ML (8MG/0.4ML) | No | No | 2024/08/26 | 2024/08/26 | ACTAVIS LLC | Prescription |
| METHYLNALTREXONE BROMIDE | 208112 | 002 | ANDA | METHYLNALTREXONE BROMIDE | SOLUTION;SUBCUTANEOUS | 12MG/0.6ML (12MG/0.6ML) | No | No | 2024/08/26 | 2024/08/26 | ACTAVIS LLC | Prescription |