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 |
2021/05/18 |
SUPPL-50(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/10/29 |
SUPPL-49(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/01/23 |
SUPPL-45(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/11/05 |
SUPPL-47(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/02/23 |
SUPPL-44(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2015/08/20 |
SUPPL-41(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/12/10 |
SUPPL-40(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/06/09 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/03/28 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/12/17 |
SUPPL-35(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/08/13 |
SUPPL-32(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/07/03 |
SUPPL-27(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/03/01 |
SUPPL-30(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2010/12/01 |
SUPPL-25(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2009/07/19 |
SUPPL-23(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2008/12/19 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2008/08/14 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/05/16 |
SUPPL-19(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/10/02 |
SUPPL-16(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/05/24 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/03/02 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/08/17 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/08/17 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2004/08/13 |
SUPPL-3(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/12/23 |
SUPPL-1(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/06/21 |
ORIG-1(原始申请) |
Approval |
Type 3 - New Dosage Form |
STANDARD
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)
与本品治疗等效的药品
活性成分:ZIPRASIDONE MESYLATE 剂型/给药途径:POWDER;INTRAMUSCULAR 规格:EQ 20MG BASE/VIAL 治疗等效代码:AP
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 |
020919 |
001 |
NDA |
GEODON |
ZIPRASIDONE MESYLATE |
POWDER;INTRAMUSCULAR |
EQ 20MG BASE/VIAL |
Prescription |
Yes |
Yes |
AP |
2002/06/21
|
VIATRIS |
211908 |
001 |
ANDA |
ZIPRASIDONE MESYLATE |
ZIPRASIDONE MESYLATE |
POWDER;INTRAMUSCULAR |
EQ 20MG BASE/VIAL |
Prescription |
No |
No |
AP |
2019/12/26
|
GLAND PHARMA LTD |
216091 |
001 |
ANDA |
ZIPRASIDONE MESYLATE |
ZIPRASIDONE MESYLATE |
POWDER;INTRAMUSCULAR |
EQ 20MG BASE/VIAL |
Prescription |
No |
No |
AP |
2022/09/15
|
MSN |