| 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 | 是否参比药物 |
是否生物等效参考标准 |
治疗等效代码 | 产品批准日期 | 申请人 | 市场状态 |
专利及市场独占权 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| METAXALONE | 203695 | 001 | ANDA | METAXALONE | TABLET;ORAL | 800MG | No | No | AB | 2017/06/15 | ACTAVIS LABS FL INC | RX | 详细信息 |
| METAXALONE | 203399 | 001 | ANDA | METAXALONE | TABLET;ORAL | 800MG | No | Yes | AB | 2013/06/21 | AMNEAL PHARMS | RX | 详细信息 |
| METAXALONE | 213836 | 001 | ANDA | METAXALONE | TABLET;ORAL | 800MG | No | No | 2020/10/21 | INGENUS PHARMS LLC | DISCN | 详细信息 | |
| METAXALONE | 204770 | 001 | ANDA | METAXALONE | TABLET;ORAL | 800MG | No | No | AB | 2016/11/22 | LANNETT CO INC | RX | 详细信息 |
| METAXALONE | 040486 | 001 | ANDA | METAXALONE | TABLET;ORAL | 400MG | No | No | AB | 2015/02/27 | MOUNTAIN | RX | 详细信息 |
| METAXALONE | 022503 | 001 | NDA | METAXALONE | TABLET;ORAL | 640MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | Yes | 2015/06/01 | PRIMUS PHARMS | RX | 详细信息 | |
| METAXALONE | 208774 | 001 | ANDA | METAXALONE | TABLET;ORAL | 800MG | No | No | 2018/09/24 | RISING | DISCN | 详细信息 | |
| METAXALONE | 040445 | 001 | ANDA | METAXALONE | TABLET;ORAL | 800MG | No | No | AB | 2010/03/31 | SANDOZ | RX | 详细信息 |
| METAXALONE | 207466 | 002 | ANDA | METAXALONE | TABLET;ORAL | 400MG | No | No | AB | 2020/03/13 | SCIEGEN PHARMS | RX | 详细信息 |
| METAXALONE | 207466 | 001 | ANDA | METAXALONE | TABLET;ORAL | 800MG | No | No | AB | 2017/08/31 | SCIEGEN PHARMS | RX | 详细信息 |
| METFORMIN HYDROCHLORIDE | 205330 | 003 | ANDA | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 1GM | No | No | 2017/10/31 | AARXION ANDA HLDING | DISCN | 详细信息 | |
| METFORMIN HYDROCHLORIDE | 205330 | 001 | ANDA | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 500MG | No | No | 2017/10/31 | AARXION ANDA HLDING | DISCN | 详细信息 | |
| METFORMIN HYDROCHLORIDE | 205330 | 002 | ANDA | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 850MG | No | No | 2017/10/31 | AARXION ANDA HLDING | DISCN | 详细信息 | |
| METFORMIN HYDROCHLORIDE | 091184 | 003 | ANDA | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 1GM | No | No | AB | 2010/11/01 | ALKEM | RX | 详细信息 |
| METFORMIN HYDROCHLORIDE | 091184 | 001 | ANDA | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 500MG | No | No | AB | 2010/11/01 | ALKEM | RX | 详细信息 |
| METFORMIN HYDROCHLORIDE | 091184 | 002 | ANDA | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 850MG | No | No | AB | 2010/11/01 | ALKEM | RX | 详细信息 |
| METFORMIN HYDROCHLORIDE | 077880 | 003 | ANDA | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 1GM | No | No | 2006/06/05 | AMNEAL PHARMS NY | DISCN | 详细信息 | |
| METFORMIN HYDROCHLORIDE | 077880 | 001 | ANDA | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 500MG | No | No | 2006/06/05 | AMNEAL PHARMS NY | DISCN | 详细信息 | |
| METFORMIN HYDROCHLORIDE | 077880 | 002 | ANDA | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 850MG | No | No | 2006/06/05 | AMNEAL PHARMS NY | DISCN | 详细信息 | |
| METFORMIN HYDROCHLORIDE | 075984 | 003 | ANDA | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 1GM | No | No | 2002/04/23 | APOTEX | DISCN | 详细信息 |
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