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 |
|---|
| 2024/08/21 |
SUPPL-12（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/08/21 |
SUPPL-7（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/08/21 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/08/21 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/11/29 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/07/05 |
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:DEXMETHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:25MG 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 |
|---|
| 021802 |
008 |
NDA |
FOCALIN XR |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
25MG |
Prescription |
Yes |
No |
AB |
2011/04/21
|
SANDOZ |
| 202842 |
005 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
25MG |
Prescription |
No |
No |
AB |
2016/11/30
|
ENDO OPERATIONS |
| 203614 |
001 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
25MG |
Prescription |
No |
No |
AB |
2017/07/05
|
IMPAX LABS INC |
| 202731 |
001 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
25MG |
Prescription |
No |
No |
AB |
2017/07/05
|
TEVA PHARMS USA |
| 210279 |
005 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
25MG |
Prescription |
No |
No |
AB |
2018/10/09
|
ADARE PHARMS INC |
| 213813 |
005 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
25MG |
Prescription |
No |
No |
AB |
2020/09/09
|
GRANULES |
| 206734 |
005 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
25MG |
Prescription |
No |
No |
AB |
2021/11/05
|
SUN PHARM INDS INC |
| 215523 |
005 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
25MG |
Prescription |
No |
No |
AB |
2021/12/08
|
ASCENT PHARMS INC |
活性成分:DEXMETHYLPHENIDATE HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:35MG 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 |
|---|
| 021802 |
007 |
NDA |
FOCALIN XR |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
35MG |
Prescription |
Yes |
No |
AB |
2011/04/21
|
SANDOZ |
| 202842 |
007 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
35MG |
Prescription |
No |
No |
AB |
2016/11/30
|
ENDO OPERATIONS |
| 203614 |
002 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
35MG |
Prescription |
No |
No |
AB |
2017/07/05
|
IMPAX LABS INC |
| 202731 |
004 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
35MG |
Prescription |
No |
No |
AB |
2017/07/05
|
TEVA PHARMS USA |
| 210279 |
007 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
35MG |
Prescription |
No |
No |
AB |
2018/10/09
|
ADARE PHARMS INC |
| 213813 |
007 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
35MG |
Prescription |
No |
No |
AB |
2020/09/09
|
GRANULES |
| 206734 |
007 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
35MG |
Prescription |
No |
No |
AB |
2021/11/05
|
SUN PHARM INDS INC |
| 215523 |
007 |
ANDA |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
35MG |
Prescription |
No |
No |
AB |
2021/12/08
|
ASCENT PHARMS INC |