美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=REMERON"
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
REMERON 020415 001 NDA MIRTAZAPINE TABLET;ORAL 15MG Yes Yes 1996/06/14 1996/06/14 ORGANON USA INC Prescription
REMERON 020415 002 NDA MIRTAZAPINE TABLET;ORAL 30MG Yes No 1996/06/14 1996/06/14 ORGANON USA INC Prescription
REMERON 020415 003 NDA MIRTAZAPINE TABLET;ORAL 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1996/06/14 1997/03/17 ORGANON USA INC Discontinued
REMERON SOLTAB 021208 001 NDA MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG Yes Yes 2001/01/12 2001/01/12 ORGANON USA INC Prescription
REMERON SOLTAB 021208 002 NDA MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 30MG Yes No 2001/01/12 2001/01/12 ORGANON USA INC Prescription
REMERON SOLTAB 021208 003 NDA MIRTAZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 45MG Yes No 2001/01/12 2001/01/12 ORGANON USA INC Prescription
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