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 |
2022/10/06 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/10/06 |
SUPPL-13(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/10/06 |
SUPPL-9(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/10/06 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/10/06 |
SUPPL-4(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/01/22 |
SUPPL-3(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/01/22 |
SUPPL-1(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/07/19 |
ORIG-1(原始申请) |
Approval |
|
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号 | 专利号 | 专利过期日 | 是否物质专利 | 是否产品专利 | 专利用途代码 | 撤销请求 | 提交日期 | 专利下载 | 备注 |
无 |
与本品治疗等效的药品
活性成分:METHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:40MG 治疗等效代码:AB2
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 |
021259 |
004 |
NDA |
METADATE CD |
METHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
40MG |
Prescription |
Yes |
No |
AB2 |
2006/02/19
|
AYTU BIOPHARMA |
078873 |
001 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
40MG |
Discontinued |
No |
No |
AB2 |
2012/07/19
|
TEVA PHARMS |
203583 |
004 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
40MG |
Prescription |
No |
No |
AB2 |
2015/09/29
|
SPECGX LLC |
205105 |
004 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
40MG |
Prescription |
No |
No |
AB2 |
2016/07/28
|
IMPAX LABS INC |
活性成分:METHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:50MG 治疗等效代码:AB2
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 |
021259 |
005 |
NDA |
METADATE CD |
METHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
50MG |
Prescription |
Yes |
No |
AB2 |
2006/02/19
|
AYTU BIOPHARMA |
078873 |
002 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
50MG |
Discontinued |
No |
No |
AB2 |
2012/07/19
|
TEVA PHARMS |
203583 |
005 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
50MG |
Prescription |
No |
No |
AB2 |
2015/09/29
|
SPECGX LLC |
205105 |
005 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
50MG |
Prescription |
No |
No |
AB2 |
2016/07/28
|
IMPAX LABS INC |
活性成分:METHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:60MG 治疗等效代码:AB2
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 |
021259 |
006 |
NDA |
METADATE CD |
METHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
Yes |
Yes |
AB2 |
2006/02/19
|
AYTU BIOPHARMA |
078873 |
003 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
60MG |
Discontinued |
No |
No |
AB2 |
2012/07/19
|
TEVA PHARMS |
203583 |
006 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB2 |
2015/09/29
|
SPECGX LLC |
205105 |
006 |
ANDA |
METHYLPHENIDATE HYDROCHLORIDE |
METHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
60MG |
Prescription |
No |
No |
AB2 |
2016/07/28
|
IMPAX LABS INC |