批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期 | 提交号 | 审批结论 | 申请内容分类 | 审评优先级;罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
2021/11/18 |
SUPPL-28(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/04/29 |
SUPPL-26(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/04/29 |
SUPPL-24(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/03/04 |
SUPPL-19(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/09/05 |
SUPPL-25(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/07/08 |
SUPPL-20(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/12/30 |
SUPPL-22(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/09/30 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/07/18 |
SUPPL-21(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2012/10/30 |
SUPPL-16(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/12/23 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2010/05/14 |
SUPPL-14(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2010/05/14 |
SUPPL-13(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2007/07/30 |
SUPPL-10(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/01/12 |
SUPPL-9(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2004/06/01 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/11/14 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/05/21 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/04/03 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/11/20 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/03/23 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/02/22 |
SUPPL-1(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/01/12 |
ORIG-1(原始申请) |
Approval |
Type 3 - New Dosage Form |
STANDARD
|
|
|
与本品治疗等效的药品
活性成分:MIRTAZAPINE 剂型/给药途径:TABLET, ORALLY DISINTEGRATING;ORAL 规格:15MG 治疗等效代码:AB
申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
021208 |
001 |
NDA |
REMERON SOLTAB |
MIRTAZAPINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
15MG |
Prescription |
Yes |
Yes |
AB |
2001/01/12
|
ORGANON USA ORGANON |
077376 |
002 |
ANDA |
MIRTAZAPINE |
MIRTAZAPINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
15MG |
Prescription |
No |
No |
AB |
2005/12/08
|
AUROBINDO PHARMA |
205798 |
001 |
ANDA |
MIRTAZAPINE |
MIRTAZAPINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
15MG |
Prescription |
No |
No |
AB |
2017/06/01
|
SQUARE PHARMS |
活性成分:MIRTAZAPINE 剂型/给药途径:TABLET, ORALLY DISINTEGRATING;ORAL 规格:30MG 治疗等效代码:AB
申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
021208 |
002 |
NDA |
REMERON SOLTAB |
MIRTAZAPINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
30MG |
Prescription |
Yes |
No |
AB |
2001/01/12
|
ORGANON USA ORGANON |
077376 |
003 |
ANDA |
MIRTAZAPINE |
MIRTAZAPINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
30MG |
Prescription |
No |
No |
AB |
2005/12/08
|
AUROBINDO PHARMA |
205798 |
002 |
ANDA |
MIRTAZAPINE |
MIRTAZAPINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
30MG |
Prescription |
No |
No |
AB |
2017/06/01
|
SQUARE PHARMS |
活性成分:MIRTAZAPINE 剂型/给药途径:TABLET, ORALLY DISINTEGRATING;ORAL 规格:45MG 治疗等效代码:AB
申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
021208 |
003 |
NDA |
REMERON SOLTAB |
MIRTAZAPINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
45MG |
Prescription |
Yes |
No |
AB |
2001/01/12
|
ORGANON USA ORGANON |
077376 |
004 |
ANDA |
MIRTAZAPINE |
MIRTAZAPINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
45MG |
Prescription |
No |
No |
AB |
2006/02/28
|
AUROBINDO PHARMA |
205798 |
003 |
ANDA |
MIRTAZAPINE |
MIRTAZAPINE |
TABLET, ORALLY DISINTEGRATING;ORAL |
45MG |
Prescription |
No |
No |
AB |
2017/06/01
|
SQUARE PHARMS |