美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=METAXALONE"
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022503 001 NDA METAXALONE TABLET;ORAL 640MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2015/06/01 2015/06/01 PRIMUS PHARMS Discontinued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
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