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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
METAXALONE | 040445 | 001 | ANDA | METAXALONE | TABLET;ORAL | 800MG | No | No | 2010/03/31 | 2010/03/31 | SANDOZ | Prescription |
METAXALONE | 203399 | 001 | ANDA | METAXALONE | TABLET;ORAL | 800MG | No | Yes | 2013/06/21 | 2013/06/21 | AMNEAL PHARMS | Prescription |
METAXALONE | 040486 | 001 | ANDA | METAXALONE | TABLET;ORAL | 400MG | No | No | 2015/02/27 | 2015/02/27 | MOUNTAIN | Prescription |
METAXALONE | 022503 | 001 | NDA | METAXALONE | TABLET;ORAL | 640MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2015/06/01 | 2015/06/01 | PRIMUS PHARMS | Discontinued |
METAXALONE | 204770 | 001 | ANDA | METAXALONE | TABLET;ORAL | 800MG | No | No | 2016/11/22 | 2016/11/22 | LANNETT CO INC | Prescription |
METAXALONE | 203695 | 001 | ANDA | METAXALONE | TABLET;ORAL | 800MG | No | No | 2017/06/15 | 2017/06/15 | ACTAVIS LABS FL INC | Prescription |
METAXALONE | 207466 | 001 | ANDA | METAXALONE | TABLET;ORAL | 800MG | No | No | 2017/08/31 | 2017/08/31 | SCIEGEN PHARMS INC | Prescription |
METAXALONE | 207466 | 002 | ANDA | METAXALONE | TABLET;ORAL | 400MG | No | No | 2017/08/31 | 2020/03/13 | SCIEGEN PHARMS INC | Prescription |
METAXALONE | 208774 | 001 | ANDA | METAXALONE | TABLET;ORAL | 800MG | No | No | 2018/09/24 | 2018/09/24 | APPCO | Prescription |
METAXALONE | 213836 | 001 | ANDA | METAXALONE | TABLET;ORAL | 800MG | No | No | 2020/10/21 | 2020/10/21 | INGENUS PHARMS LLC | Discontinued |