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 |
2023/10/24 |
SUPPL-17(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/11/16 |
SUPPL-16(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/11/01 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/10/01 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/05/21 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2017/07/27 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/09/09 |
SUPPL-6(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2014/12/02 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/10/27 |
SUPPL-4(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/04/28 |
SUPPL-3(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2013/10/22 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/07/09 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/02/01 |
ORIG-1(原始申请) |
Approval |
Type 3 - New Dosage Form |
PRIORITY
|
|
|
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:MESALAMINE 剂型/给药途径:CAPSULE, DELAYED RELEASE;ORAL 规格:400MG 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 |
204412 |
001 |
NDA |
DELZICOL |
MESALAMINE |
CAPSULE, DELAYED RELEASE;ORAL |
400MG |
Prescription |
Yes |
Yes |
AB |
2013/02/01
|
ABBVIE |
207873 |
001 |
ANDA |
MESALAMINE |
MESALAMINE |
CAPSULE, DELAYED RELEASE;ORAL |
400MG |
Prescription |
No |
No |
AB |
2019/05/09
|
TEVA PHARMS USA |