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 |
2023/10/13 |
SUPPL-23(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/06/25 |
SUPPL-18(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2017/01/24 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/01/04 |
SUPPL-12(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2016/05/27 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2016/05/13 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/07/13 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/04/17 |
SUPPL-4(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2013/12/12 |
SUPPL-3(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/08/09 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/05/15 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2012/09/27 |
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:METHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:FOR SUSPENSION, EXTENDED RELEASE;ORAL 规格:5MG/ML 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 |
202100 |
001 |
NDA |
QUILLIVANT XR |
METHYLPHENIDATE HYDROCHLORIDE |
FOR SUSPENSION, EXTENDED RELEASE;ORAL |
5MG/ML |
Prescription |
Yes |
Yes |
AB |
2012/09/27
|
NEXTWAVE |
206049 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
FOR SUSPENSION, EXTENDED RELEASE;ORAL |
5MG/ML |
Prescription |
No |
No |
AB |
2018/05/17
|
ACTAVIS LABS FL INC |